Posted on May 7, 2010 by Lisa Baird

Ninth Circuit Court of Appeals Holds that the FDCA Precludes Plaintiff's Claim Under the Lanham Act

This post was written by Christopher C. Foster.

The Ninth Circuit recently confronted an issue of first impression: whether a plaintiff could maintain an action under the false advertising prong of the Lanham Act, where a determination of the alleged falsity would require the court to impinge on the exclusive purview of the Food and Drug Administration (FDA) in deciding whether there has been a violation of the Food, Drug, and Cosmetic Act (FDCA). Although limited to the particular circumstances presented, the opinion reaffirmed the exclusive authority of the FDA to enforce the provisions of the FDCA, and indicates that a plaintiff may not maintain a lawsuit premised on the allegation of a violation of the FDCA, where the FDA itself has not acted. 

PhotoMedex v. Irwin

In PhotoMedex v. Irwin, No. 07-56672, 2010 U.S. App. LEXIS 7640 (9th Cir. Apr. 14, 2010), the Ninth Circuit held that the FDCA, which prohibits private enforcement of its provisions, bars a medical device manufacturer’s claim under the Lanham Act. PhotoMedex involved a Lanham Act claim based upon the allegation that plaintiff PhotoMedex, Inc’s (“PhotoMedex”) competitor made false and misleading statements regarding FDA approval of a medical device marketed by the competitor. The Ninth Circuit concluded that PhotoMedex could not maintain its Lanham Act claim, because resolution of the question of whether the defendant made false statements required litigation of an underlying FDCA violation, a determination reserved to the FDA. 

Background

PhotoMedex – a direct competitor of defendants Ra Medical Systems, Inc. and Dean Stewart Irwin (collectively, “Ra Medical”) – alleged that Ra Medical engaged in misleading advertising in violation of the Lanham Act by representing that its dermatological laser product had been approved by the FDA. The device at issue – the Pharos EX-308 Excimer Laser System (“Pharos”) – is considered to be a Class II medical device under the Medical Device Amendments of 1976 (MDA) to the FDCA. The regulatory scheme provided by the FDCA and MDA, which governs FDA approval of the laser, was therefore central to the court’s decision. 

A manufacturer of a Class II medical device must obtain “clearance” from the FDA under what is known as the “510(k)” process under the MDA, before it markets the product. Alternatively, a Class II device deemed “substantially equivalent” to a pre-existing FDA-approved device, may be marketed without further regulatory analysis. A device manufacturer, however, must submit a new 510(k) application if a Class II device is about to be “significantly changed or modified in design, components, method of manufacture, or intended use.” It is the responsibility of the manufacturer of a Class II device to pursue a new 510(k) application. 

Ra Medical – which had previously obtained a licensing agreement to sell a third company’s “EX-308” laser (“SurgiLight”) – did not submit a new 510(k) application for the Pharos device. Rather, Ra Medical took the position that the Pharos was “substantially equivalent” to the SurgiLight, which had previously received FDA clearance under 510(k). Ra Medical argued that, because the Pharos was “substantially equivalent” to the SurgiLight, its representation that the Pharos had FDA approval was not false or misleading.

Legal Analysis

The Ninth Circuit, focusing on the regulatory scheme governing the “clearance” process for the medical device at issue, held that PhotoMedex could not maintain its cause of action for a violation of the Lanham Act. Specifically, the court explained that litigation of PhotoMedex’s Lanham Act cause of action would require the trial court to determine whether the Pharos was in fact “substantially equivalent” to the SurgiLight. Such a determination was prohibited because it would conflict with the statute prohibiting private enforcement of the FDCA, which provides that “all such proceedings for the enforcement, or to restrain violations, of [the FDCA] shall be by and in the name of the United States.” 

The court’s reasoning suggests that the opinion may not be as broad as it would appear at first blush, and is properly read as limited to the facts presented. The court stated that its opinion did “not suggest that the Lanham Act can never support private party claims involving FDA approval or clearance of drugs or medical devices.” Rather, a plaintiff may not pursue such a claim where the FDA “ha[d] not itself concluded there was such a violation.” 

In the case of the Pharos, the court explained that although PhotoMedex had complained on different occasions to the FDA that the Pharos had been promoted without 510(k) clearance, the FDA never reached such a conclusion. At one point in 2005, the FDA inspected the Pharos manufacturing plant , specifically discussing the clearance issue with Ra Medical. The FDA, however, never took further action. Additionally, in 2007, the FDA responded to a 510(k) notification from Ra Medical regarding additional indications for use of the laser by finding the laser “could proceed to market” for the new indications. In sum, although the FDA had the opportunity to take enforcement action against Ra Medical for the alleged violations, it never opted to do so.  

Of additional significance to the court was the fact that FDA approval itself never depended upon an affirmative statement from the FDA to the effect that the product had clearance under 501(k). Rather, the approval itself depended in the first instance on the manufacturer’s decision that the product was “substantially equivalent” to an already approved device. The mere fact that the FDA had not affirmatively approved the Pharos, therefore, did not mean the device did not have clearance under the approval of the SurgiLight. 

Accordingly, PhotoMedex was not permitted to “circumvent the FDA’s exclusive enforcement authority” by attempting to prove that Ra Medical violated the FDCA, where the FDA had not reached that conclusion, and where the regulatory scheme permitted marketing the device without an affirmative statement of approval from the FDA. To rule otherwise would “permit PhotoMedex to assume enforcement power which the statute does not allow and require the finder of fact to make a decision that the FDA itself did not make.”
Tags: , , , , , ,
Posted on November 17, 2009 by Lisa Baird

FDA Discusses Social Media Advertising Regulation for the Life Sciences Industry

This post was written by Dana Blanton.

On November 12 and 13, 2009, the FDA hosted public hearings to vet the potential need for regulation of prescription pharmaceutical and medical device marketing on social media outlets such as YouTube, Wikipedia, Facebook, and Twitter. The FDA specifically sought input on these five questions: (1) For what online communications are manufacturers, packers or distributors accountable? (2) How can manufacturers, packers, or distributors fulfill regulatory requirements in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications? (3) What parameters should apply to the posting of corrective information on Web sites controlled by third parties? (4) When is the use of links appropriate? and (5) Questions specific to Internet adverse event reporting.

The hearings attracted both internet and ethical drug and device industry giants, as well as nonprofit organizations seeking to gain a better understanding of what will certainly be a new frontier for advertising these regulated products. The FDA's existing regulations for print and television advertising are widely considered unsuitable for social media outlets, some of which allow for no more than 140 characters per post--far too few to include FDA-mandated safety information--and most of which allow for uncensored layperson commentary sometimes indistinguishable from manufacturer content. As a result, pharma and medical device representatives reported, drug and device companies have been reluctant to venture into the social media advertising field. Meanwhile, media and marketing firms offered pre-packaged advertising solutions and industry critics suggested that the FDA and pharmaceutical and device companies should bear the burden of correcting misinformation on third party websites and blogs. The FDA will consider the commentary and determine whether guidelines should be promulgated.

Information on the hearing, including background, further information regarding the five issues presented, a link to transcripts of the FDA's 1996 hearing on internet advertising and other information may be found in the Federal Register Notice for the hearing and transcripts of the November 12 and 13, 2009 hearings will be available by approximately December 13, 2009.

Tags: , , , , , ,
Posted on August 11, 2009 by Lisa Baird

Chinese Regulations on Medical Device Advertisements

This post was written by Hugh Scogin, Gordon Schatz, Amanda Tao and Amanda Yang.

On May 20, 2009, China's State Administration of Industry and Commerce, the Ministry of Health, and the State Food & Drug Administration together issued new regulations for medical device manufacturers and distributors who advertise medical devices and diagnostic products, entitled, "Measures for the Examination of Medical Device Advertisements" and "Standards for the Examination and Release of Medical Device Advertisements." To read a summary of key points contained in the regulations, click here.

Tags: , , , , ,
Posted on August 5, 2009 by Michelle H. Lyu

Senate Committee Meets To Hear From Witnesses Regarding "The Medical Device Safety Act of 2009"

On Tuesday, August 4, 2009, the Senate Committee on Health, Education, Labor and Pensions met for a hearing called "Protecting Patients from Defective Medical Devices" regarding Senate Bill 540, a companion bill to the House bill, H.R. 1346, the "Medical Device Safety Act of 2009." The House Subcommittee on Health, of the Committee on Energy and Commerce also met earlier this year on this issue, with some of the same speakers. 

S. 150 and H.R. 1346 seek to overturn the Supreme Court's important ruling in Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008), which held that the PMA approval process for Class III devices imposes federal requirements that preempt state tort claims which would impose additional or different "requirements" regarding the safety and efficacy of the device, pursuant to the express preemption clause found in the Medical Devices Amendment of 1976.

Speaking in support of the bill were William Maisel, Director of the Medical Device Safety Institute, Thomas McGarity, Professor at the University of Texas School of Law, and Michael Mulvihill, a patient who was formerly implanted with a medical device. The arguments they presented echoed those of preemption opponents.

Dr. Maisel's testimony came from the perspective of a medical practitioner, and while he praised the work of the FDA as a "preeminent medical regulatory system," it was his opinion that the FDA nevertheless could not regulate all safety and effectiveness issues that arise regarding PMA approved devices. Dr. Maisel also was of the opinion that medical device manufacturers fail to properly report medical device adverse events that in turn allegedly restricted the FDA's ability to properly regulate the industry, and in his view tort liability was an additional safeguard that Congress should restore. Professor McGarity echoed this perspective from a legal standpoint and suggested that innovation would not suffer (although he did not offer any objective support for this theory). Patient Mulvihil provided his thoughts about an allegedly defective lead he received. 

Speaking in opposition to the bill were former Chief Counsel for the FDA, Peter Barton Hutt, and medical device patient Michael G. Roman. Mr. Hutt gave a historical account of how the Medical Devices Amendments of 1976, which included the express preemption clause in question, came to fruition. As Chief Counsel during 1971-1975, he came before the House Subcommittee on Public Health and Environment of the Committee on Interstate and Foreign Commerce at that time to support national uniform standards for medical devices in order to "strengthen[] the integrity, credibility, and primary jurisdiction of the agency." From this sub-committee hearing, "all medical device legislation considered in the House and Senate included some form of national uniformity requirement." Mr. Hutt warned that if the current Senate reverses the standards put in place through the 1976 Medical Device Amendments, judges and juries in product liability cases would make decisions inconsistent with FDA decisions to approve devices for market. Mr. Hutt also went on to describe the rigor of the PMA approval process that is applicable only for less than 1/2 of 1% of medical devices on the market.

The last witness of the day was patient Michael Roman, who testified about the importance of medical device innovation and availability from his personal experience. After multiple surgeries to repair a torn knee ligament that resulted in a staph infection and later progressive amputations of his right leg, Mr. Roam testified that prior to his medical device, he was under so much pain that he could not remember ten years of his children's' lives. Mr. Roman also testified that he was only able to live with large amounts of pain medication, radiation and injections to no avail. It was only after the implantation of a spinal cord stimulator (which delivers certain electrical impulses through leads to his spinal cord) that his pain has been managed effectively. He currently works with Boston Scientific in speaking out about the debilitating nature of pain and how medical technologies could assist patients in living full lives. His focus was that safe, innovative products should be approved through a more robust FDA, not through the vagaries of litigation that would result from the passage of the bill.

The limited time available during these hearings means that the witnesses often can only scratch the surface, and there is so much more to be said about why the Medical Device Safety Act of 2009 is a bad idea. For a more detailed perspective, it is worth reading “The Economic Impact of Eliminating Federal Preemption for Medical Devices on Patients, Innovation and Jobs” by Ernst Berndt, PhD, and Mark Trusheim of the Massachusetts Institute of Technology’s Sloan School of Management.

Tags: , , , , ,
Posted on July 29, 2009 by Lisa Baird

Next Congressional Hearing About Medical Device Safety Announced

On August 4, 2009 at 2:30 p.m., it will be the Senate's HELP Committee's turn to hold a hearing entitled "Protecting Patients from Defective Medical Devices". No witness list is yet posted.

For our coverage on past hearings on this issue, click here.

Tags: , , , , , ,
Posted on June 17, 2009 by Michelle H. Lyu

Courts Continue To Get Express Preemption Right In Medical Device Cases

Since last year, a number of courts have interpreted and applied the express preemption holdings of Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008). Miller v. DePuy Spine, Inc., 07-cv-01639, 2009 US Dist LEXIS 49602 (D. Nev. May 1, 2009), is another example and, although it was decided on May 1, has just recently been picked up by LEXIS.

In Miller, the Nevada District Court granted summary judgment for the manufacturer of a PMA approved spinal implant disc called the Charite Artificial Disc. While many courts, including this one, correctly follow Riegel and hold that the state law claims challenging the design, manufacture and labeling claims are expressly preempted, this court also entered judgment for the defendant on warranty and misrepresentation claims that have a received a more mixed reception in some courts.

As to express warranty, Miller concluded that the plaintiff failed to establish the receipt of any express warranties, and that such warranty claims directly challenged the safety and effectiveness established through PMA approval of the device. The Court further held that even when couched as a warranty claim , claims are preempted when they would "impose liability for the defendant's use of labeling approved and required by the FDA." 

The plaintiff also claimed to assert "parallel claims" contending  that the implanted device was "out of conformity with the materials or manufacturing specifications approved by the FDA," but the court dismissed these as well because plaintiff failed to meet his burden in demonstrating that there was a genuine issue of fact. As the Court succinctly noted: "Only a departure from such FDA-approved specifications could conceivably escape preemption, and absence of any evidence of such departure justifies summary judgment." 

Plaintiff's claims that the manufacturer allegedly made misrepresentations or omissions of material information to the FDA in order to "secure or maintain the PMA" were also dismissed. Not only had the plaintiff offered only "argument about this hypothesis" rather than admissible evidence, under 21 U.S.C. Section 337(a), any attempt to enforce the FDCA and its regulations were preempted; and any contention that the manufacturer provided inaccurate or incomplete information to the FDA was impliedly preempted under Buckman v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001). 

Tags: , ,
Posted on June 5, 2009 by Lisa Baird

Congressional Hearings On Medical Device Regulation, Litigation Protective Orders

Congress has been busy and there is no sign it intends to slow down just because it is summer.

In two weeks, the House Energy and Commerce Health Subcommittee will hold a hearing entitled, "Medical Devices: Are Current Regulations Doing Enough for Patients." The hearing will be on June 18th at 9:30 a.m. in 2322 Rayburn House Office Building and access to the webcast and witness list should be available from this page once available. Information about this subcommittee's May 12th hearing about medical device preemption is in this prior post.

Earlier this week, the House Judiciary Committee held a hearing on a bill to curtail the discretion of federal judges in issuing litigation protective orders under Federal Rule of Civil Procedure 26(c ) and limiting the use of confideniality provisions in litigation settlement agreements subject to court approval or filed with the court. Proponents of this bill, the "Sunshine in Litigation Act of 2009", H.R. 1508, suggest that it is needed to help keep defendants in civil litigation from "hiding" health and safety hazards.

As the Supreme Court recognized in Seattle Times Co. v. Rhinehart, 467 U.S. 20, 33 (1984), discovery materials are not public components of a civil trial. Until information produced in discovery is filed with the court or introduced into evidence for determination of a merits issue (such as on a motion for summary judgment or at trial), protective orders routinely protect the confidential and proprietary information of parties to civil litigation.

Testimony by the Hon. Mark R. Kravitz of the District of Connecticut, on behalf of the Conference’s Committee on Rules of Practice and Procedure and its Advisory Committee on Civil Rules, opposed the bill on the ground that it effectively amends the Federal Rules of Civil Procedure outside the rulemaking process, contrary to the Rules Enabling Act (28 U.S.C. §§ 2071-2077). He testified that the bill is not needed (emphasis added):

In 1994, the Rules Committees asked the Federal Judicial Center (FJC) to do an empirical study on whether discovery protective orders were operating to keep information about public safety or health hazards from the public. The FJC completed the study in April 1996. . . . The FJC study showed that discovery protective orders were requested in only about 6% of the approximately 220,000 civil cases filed in federal courts in that time period. Most of the requests are made by motion. Courts carefully review these motions and deny or modify them in a substantial proportion. Less than one-quarter of the requests are made by party stipulations and the courts usually accept them. In most civil cases in which discovery protective orders were entered, the empirical study showed that the orders did not impact public safety or health. . . . The empirical data showed no evidence that protective orders create any significant problem of concealing information about public hazards.
* * * *
Even when a protective order is entered, it usually does not result in the sealing of all, or even many, documents or information submitted to the court. Case law shows that courts are rightly protective of the public’s right to gain access to information and documents submitted to the courts.
* * * *
Requiring courts to review discovery information to make public health and safety determinations in every request for a protective order, no matter how irrelevant to public health or safety, will burden judges, further delay pretrial discovery and inevitably increase the cost of civil litigation in federal courts.

We've attached a copy of the Federal Judicial Center's Report.  Additional testimony on the bill is available here.

Tags: , , ,
Posted on May 28, 2009 by Debra A. McCurdy

New Proposed DTC Advertising Guidelines

On May 27, 2009, the Food and Drug Administration (FDA) published a notice soliciting comments on a draft guidance document entitled “Presenting Risk Information in Prescription Drug and Medical Device Promotion.” The draft guidance proposes to use a “reasonable consumer” standard, similar to the Federal Trade Commission's standard, for assessing whether advertisements are misleading, a standard FDA already applies to labels on food and dietary supplements. In the draft guidance, FDA discusses the factors the agency would consider when evaluating prescription drug and restricted device promotional materials directed at healthcare professionals and consumers. The factors include: consistent and appropriate use of language, use of signals, framing of risk information, and the hierarchy of risk information. FDA also states that the agency will review content for both quantity of risk information, as well as materiality and comprehensiveness. Finally, FDA provides extensive factors it considers when evaluating the format of promotional materials. Comments should be submitted by August 25, 2009; for information on submitting comments, click here.

Tags: , ,
Posted on May 13, 2009 by Michelle H. Lyu

House Subcommittee Holds Hearing To Overturn Riegel: H.R. 1346, the "Medical Device Safety Act of 2009"

On May 12, 2009 the Subcommittee on Health, of the Committee on Energy and Commerce, House of Representatives, held a hearing on H.R. 1346, the "Medical Device Safety Act of 2009".  If passed, it would overturn the Supreme Court decision, Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008), which held that under the express preemption clause of the Medical Devices Amendment of 1976 (MDA), the federal requirements created by the premarket approval process for Class III devices preempted state law tort claims that added or differed from the federal requirements.  This hearing comes at the heels of public and media scrutiny of this decision, including last year's House Committee on Oversight and Government Reform preemption hearing held May 14, 2008 and the Senate Judiciary Committee's preemption hearing held June 11, 2008.

Before the invited panel of witnesses spoke, numerous members of the subcommittee provided opening remarks, which reflected the division among those who argued that the Supreme Court's analysis in Riegel departed from the legislative intent of the MDA, and those who agreed that the pending legislation would prevent innovation and access to medical devices that are life-saving. Arguments against the bill also noted that moving against preemption would otherwise place safety concerns in the hands of juries across the country, instead of on the FDA's safety and efficacy evaluations. Some focus was also placed on the FDA's effectiveness in policing the manufacturers, with several congress members such as Representative John Dingell, MI and Henry Waxman, CA arguing that the FDA has not been able to identify and take action on defective products, therefore calling into question their effectiveness in ensuring safety, while other congress members such as Representatives Steve Buyer, IN and Michael Burgess, TX argued that if the FDA is underfunded and without resources, the Committee should focus on the FDA, not on tort reform.

Most of the invited witnesses were repeat appearances from last year's hearing. David Vladeck, J.D., Professor of Law, Georgetown University Law Center presented his case in support of the bill, and repeated his concerns about the Riegel court's alleged deviation from congressional intent as reflected in legislative history. He also argued that manufacturers brought the express preemption defense to fore and that it was a more recent phenomena since the mid 1990s, after the Cipollone v. Liggett Group, Inc., 505 U.S. 504, 517, 112 S.Ct. 2608, 2618 (1992) decision.

William H. Maisel, M.D., M.P.H., Director, Medical Device Safety Institute, Department of Medicine, Beth Israel Deaconess Medical Center, Boston also testified, as both a practicing cardiologist and as a consultant and advisory committee member for the FDA. He provided anecdotal background with what he represented as an example of a man who was implanted with a St. Jude pacemaker that allegedly was subjected to a recall and resulted in additional surgical procedures.  In making this example, Dr. Maisel argued that the self-interest of companies are at odds with the congressional goal of ensuring public safety. Gregory Curfman, M.D., Executive Editor, New England Journal of Medicine also echoed similar sentiments, and discounted the arguments made about innovation and safety for consumers being mutually exclusive.

Richard Cooper of the law firm Williams & Connolly LLP provided a big-picture review of what it would mean to have 50 state juries take the place of the FDA and seasoned clinicians when determining what constitutes a "defect" meriting liability. Mr. Cooper also emphasized that innovation would be hampered should preemption be denied to medical device companies, noting how many smaller companies that are focused on under-served areas of practice would be litigated out of their market share.

Bridget Robb of Pennsylvania and Michael Kinsley of Washington both presented anecdotal history with medical devices. Ms. Robb testified about her experience with a cardiac lead that she claimed unnecessarily shocked her and caused grievous subsequent emotional and physical injury, while Mr. Kinsley presented his story of how deep brain stimulation and other implanted medical devices has allowed him to lead a productive life despite a Parkinson's Disease diagnosis. Both presented different takes on the limits of how much risk a patient should face when balanced with the potential benefits offered by their medical devices.

Prior to the hearing, the Energy & Commerce Committee also published a letter asking the FDA to reexamine its decision to approve a medical device called the "collagen scaffold" that is used to reinforce and repair the meniscus, which is a natural cushion in the knee. This letter, as addressed to the FDA Principal Deputy Commissioner, seeks reexamination of the approval decision that the authors argue was made over the objection of FDA scientists.

For more information, please see the previous post "Will The May 12 Hearing On The "Medical Device Safety Act of 2009" Recognize The Costs Of Eliminating Preemption?"

Tags: , , , , , ,
Posted on May 8, 2009 by Lisa Baird

Will The May 12 Hearing On The "Medical Device Safety Act of 2009" Recognize The Costs Of Eliminating Preemption?

The House Committee on Energy and Commerce's Subcommittee on Health will hold a hearing on Tuesday, May 12, 2009, at 2:00 p.m. regarding a bill to overturn medical device preemption (H.R. 1346 /S. 540), called the "The Medical Device Safety Act of 2009.” Although the hearing is not yet listed on the Subcomittee's website, hearing materials should become available here. (If you are interested, video and transcripts also are available from last year's lopsided House Committee on Oversight and Government Reform preemption hearing held May 14, 2008 and the Senate Judiciary Committee's preemption hearing held June 11, 2008.)

Those in the industry will find H.R.1346/ S. 540 ironically named, as patient access to critical new devices and public health would suffer if this bill passes. These ill effects are detailed in a new economics study, “The Economic Impact of Eliminating Federal Preemption for Medical Devices on Patients, Innovation and Jobs” by Ernst Berndt, PhD, and Mark Trusheim of the Massachusetts Institute of Technology’s Sloan School of Management. As the authors state in the executive summary to their article,

"Eliminating preemption protection for medical devices—as some currently advocate—will impact:

1. Patient access and public health
2. Medical technology innovation rates
3. Industry employment
4. Government expenses as a healthcare payer, regulator and judicial funder

The results from eliminating preemption are likely broad and generally negative across this host of categories."

The article is thoughtful and well worth reading.

Tags: , , , , , ,
Posted on January 30, 2009 by Lisa Baird

Commentary: FDA's New Good Reprint Practice Rule

This post was written by Areta L. Kupchyk, James M. Wood and Kevin M. Madagan.

FDA's Good Reprint Practice (GRP) Guidance went into effect in January 2009. The GRP Guidance establishes criteria that FDA will now use to determine whether the distribution of medical or scientific reprints and reference texts about off-label uses of a drug or device would constitute impermissible promotional activity under the Food, Drug and Cosmetic Act.

Read Reed Smith’s full commentary analyzing the GRP Guidance, which includes a Good Reprint Practice Checklist.

Tags: , , , , , , , , , ,
Posted on January 27, 2009 by Debra A. McCurdy

Good Reprint Practices

The FDA published a notice on January 13, 2009 announcing a final guidance document entitled “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.” The guidance, which finalizes a February 20, 2008 draft policy, is intended to provide manufacturers with the agency's views on permissible distribution by a company's sales representatives of medical journal articles and scientific or medical reference publications that discuss unapproved new uses for FDA-approved drugs or biologics or FDA-approved or cleared medical devices to healthcare professionals. As with the 2008 draft guidance, the final version notes the need to balance the law’s prohibition on distributing or promoting “unapproved uses of approved drugs and approved or cleared medical devices” with the “important public policy” of providing information that “may even constitute a medically recognized standard of care.” The FDA concludes that the touchstone for lawful dissemination of literature about unapproved uses is that the publications “are truthful and non-misleading.” To meet this standard, the FDA final guidance lists “principles of Good Reprint Practices” that include criteria for determining the type of publication and the manner in which the publication can be distributed. Although the final guidance closely tracks the draft guidance, it has some important clarifications, including revisions to the Good Reprint Practices and a specific reference encouraging manufacturers to seek approvals and clearance for new indications and intended uses for medical products.   A Reed Smith analysis of the final guidance is available here.

Tags: , , , ,
Posted on September 26, 2008 by Paul B. Kerrigan

Senate Hearing on DTC Advertising for Medical Devices

The United States Senate Special Committee on Aging heard testimony Sept. 17, 2008, to consider recommendations on whether increased regulation of direct-to-consumer (“DTC”) advertising is needed for restricted medical devices regulated by FDA, such as heart stents, replacement hips, and other implanted medical devices. (The Federal Trade Commission regulates advertising for non-restricted medical devices.) 

Describing its inquiry as “Marketing or Medicine: Are Direct-to Consumer Medical Device Ads Playing Doctor?” the hearing was another in the committee’s on-going, 15-month series of oversight hearings on medical device and pharmaceutical marketing practices. Committee Chairman Sen. Herb Kohl (D-Wis.) observed in his opening remarks that the pharmaceutical industry has spent “billions of dollars advertising their products directly to consumers” since the mid-1990s, while the medical device industry is “just beginning to get into the game.” (According to AdvaMed’s President and CEO, Stephen J. Ubl, pharmaceutical companies spent $2.46 billion on DTC ads in 2005 while medical device companies spent $116 million.) 

Whether the Committee is poised to act is unclear. In his opening statement, Sen. Kohl said that, depending upon what his committee learned during the hearing, he was prepared to work with Rep. John Dingell (D-Mich.) to consider legislative measures similar to the American Medical Association (“AMA”) 2006 call for enhanced regulation of DTC advertising by FDA. At the conclusion of the hearing, however, Sen. Kohl said that “we’re not yet of a mind to propose legislative solutions,” although he plainly indicated that he, his committee, and staff members would stay “very, very much on top” of this issue.

CDRH Overview of Existing Regulation of DTC for Devices

Daniel Schultz, M.D., Director of FDA’s Center for Radiological Health (“CDRH”), provided a comprehensive overview of current medical device DTC regulation for the Committee. FDA’s device regulations do not contain specific requirements regarding the content of advertisements for restricted medical devices, in contrast to regulations for prescription drug advertising. Regulation of restricted device advertising comes directly from the Federal Food, Drug and Cosmetic Act – specifically sections 502(q) and (r). These sections provide that a restricted device is misbranded if its advertising is false or misleading in any particular, and does not contain a brief statement of the device’s intended use and relevant warnings, precautions, side effects, and contraindications. Dr. Schultz explained that the FDA’s February 2004 Guidance Document is intended to help companies comply with the statutory requirements.

CDRH regulates only two of the three different types of DTC device ads – the “product claim” and the “promotional reminder” ads. “Product claim” ads are those that generally include both the name of a product and its indications for use, or make a claim or representation about a medical device. “Promotional reminder” ads may disclose the name of the medical device and certain descriptive information or price information, but they do not give the device’s indications for use or make any claims or representations about the device.

The third type of DTC device ad – “help seeking and disease awareness communications” – does not constitute labeling or advertising and, therefore, is not subject to FDA regulation. Disease-awareness communications discuss a particular disease or health condition and are disseminated to health care practitioners, while help-seeking communications are essentially disease-awareness communications directed to consumers. Neither mentions any specific device or makes any representation or suggestion concerning a particular device.

CDRH’s Office of Compliance (“OC”) is responsible for the surveillance and enforcement of violations contained in the promotional materials of all medical device companies. Dr. Schultz noted that the OC’s primary source of promotional violations by device companies comes from competitors and information obtained by OC personnel who attend various science meetings at which devices are discussed and exhibited. In general, OC’s involvement is limited to circumstances after the materials have appeared in the public domain.

Witness Testimony

Hearing witnesses came from the medical profession, advertising and consumer protection groups, FDA, and AdvaMed. While all agreed that DTC advertising of medical devices is an important issue, there was no agreement about whether device ads should be regulated, or regulated in the same manner and to the same degree as those for prescription drugs. 

For example, Dr. Schultz agreed with Sen. Kohl that regulation of DTC advertising for medical devices is “important,” but declined the senator’s invitation to answer a question in the affirmative about whether there should be the same level of regulation by FDA for prescription drug and medical device DTC ads. Dr. Schultz, who described himself as “a surgeon and a device guy,” said medical devices “need to be regulated to the extent necessary to protect public health,” noting that the real issue is how FDA accomplishes such a mission and whether it does it efficiently. Dr. Schultz said that FDA and CDRH will look at whatever ideas the committee has to offer and provide comments on what it believes will be “effective regulation.” Making a strong statement for the value of the “learned intermediary,” Dr. Schultz said that “[a]t the end of the day, the ultimate decision of what is the best treatment rests with the doctor and the patient.”

The witnesses from the medical profession supported greater FDA oversight of DTC advertising for medical devices, combined with greater restraint by device manufacturers in using DTC advertising. In fact, when asked by Sen. Ken Salazar (D-Colo.) whether Congress ought to consider banning DTC advertising as other countries have done, William E. Boden, M.D., professor of medicine and public health at the University of Buffalo, said that “most would prefer it,” although he did not explain precisely who was included in the term “most,” and acknowledged that such an action would likely trigger court challenges. Dr. Boden concluded his response by saying that “it [the ban] would be worthy of consideration if you could navigate around the First Amendment issue.” Ruth Day, Ph.D., a witness from Duke University, interjected that other countries have not banned DTC advertising; rather, they simply have not approved it.

Kevin J. Bozic, M.D., M.B.A., an orthopaedic surgeon from the University of California at San Francisco, spoke on behalf of the American Association of Orthopaedic Surgeons. He is the co-author of a 2007 study critical of the impact of DTC advertising in orthopaedics (Bozic, K.J., Smith, A.R., Hariri, S., et al. “The Impact of Direct-to-Consumer Advertising in Orthopaedics,” Clin Orthop Relat Res.2007; May: 458:208-19). The study surveyed practicing orthopaedic surgeons who perform hip and knee replacement surgery and patients who were scheduled to undergo such surgery. The study concluded that DTC ads had a substantial influence on both patient and surgeon decision-making. At the same time, Dr. Bozic acknowledged that more studies are necessary to evaluate the effects of DTC advertising on physicians and patients.

In contrast to Dr. Bozic, Dr. Boden emphasized that, given the sophisticated medical understanding required for devices used in interventional cardiology, it is extremely unlikely that a lay person would possess such an understanding on the basis of a 30-second television ad. As Dr. Boden put it in his written testimony, “[i]t seems highly unlikely that an interventional cardiologist would accede to a patient’s request for a particular stent type, based solely on the patient’s very limited information derived from a DTC ad that touts one particular [stent].”

Among his recommendations, Dr. Boden believes that FDA should place drugs and devices on the same regulatory footing with respect to DTC advertising, requiring evidence-based clinical data to demonstrate proved clinical benefits of the device being advertised. In this vein, Dr. Boden alluded to the model developed and used by New Zealand. In that country, all ads making therapeutic claims for advertised products must first be pre-approved by the Association of New Zealand Advertisers, Therapeutic Advertising Pre-Vetting Service, which promotes an industry-based, self-regulatory advertising code of conduct that encourages fair balance of risks and benefits in advertising content. Dr. Boden suggested that the FDA establish a similar panel under the Federal Advisory Committee Act that could either itself recommend standards for DTC device ads, or develop a new set of standards for self-regulation.  Finally, Dr. Boden favors a ban on all DTC device ads for the first two years following FDA approval to assure that an appropriate safety record is established prior to advertising to the public. 

Dr. Day, the Director of the Medical Cognition Laboratory at Duke University and Senior Fellow at the Duke Center for the Study of Aging, testified about research into how people understand and remember information in DTC advertising. She opined that it was important for both benefits and risks to be presented in “cognitively accessible” ways.

Not surprisingly, a witness from Consumers Union urged Congress to require FDA to conduct the same kind of oversight and regulation of DTC ads for implantable medical devices as the agency is now authorized to do for drug ads, and called for Congress to require FDA review of DTC device ads prior to being issued.

The final witness of the day was Mr. Ubl from AdvaMed. He stressed four key points in his testimony. First, AdvaMed’s member companies believe strongly that DTC advertising of medical devices must provide truthful and non-misleading information to consumers. Second, such advertising can benefit the public health by informing patients of important potential therapies that they should discuss with their physicians. Third, FDA and FTC already have ample legal authority to regulate false and misleading advertising for medical devices, and AdvaMed believes that FDA resources in this area should be focused on enforcement issues. And fourth, concerns about DTC advertising in the drug context are in many cases less relevant when applied to restricted devices, which not only are prescribed by doctors but are used or implanted by doctors as well.
Tags: , ,