Archives: Clinical Trials

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Updates Regarding the Pacira Pharmaceutical Inc. v. FDA Lawsuit Regarding First Amendment and Off-Label Promotion Issues

As readers of this blog know, following Amarin’s success in obtaining a preliminary injunction limiting FDA enforcement action against it for truthful, non-misleading off-label promotion of its prescription drug Vascepa, Pacira Pharmaceuticals filed a similar lawsuit regarding off-label promotion of its prescription drug Exparel. While we await the FDA’s response to Pacira’s motion for preliminary … Continue Reading

Change Coming to FDA’s “Intended Use” Regulations?

Over at the Drug And Device Law Blog, our colleagues call attention to proposed changes to the “intended use” regulations for prescription drugs and devices, 21 C.F.R. §201.128 and 21 C.F.R. §804.1, somewhat hidden within a proposed rule regarding tobacco published in the Federal Register on September 25, 2015. As the FDA explained, the changes … Continue Reading

First Amarin Pharm v. FDA, Now Pacira Pharm, Inc. v. FDA

The Southern District of New York certainly is becoming a hotbed for issues relating to the FDA’s ability to take enforcement action against manufacturers who promote their FDA-regulated products for uses outside the approved label indications.  The Amarin Pharm v. FDA litigation has garnered a good deal of attention, and after Amarin and the FDA … Continue Reading

What Comes Next In Amarin Pharm v. FDA?

The Southern District of New York’s preliminary injunction in Amarin Pharm, Inc. v. FDA—prohibiting the FDA from taking action against Amarin over truthful, non-misleading “off-label” statements about its prescription drug Vascepa—understandably has been big news, analyzed here  and  elsewhere. Some are asking whether the FDA will pursue appellate review of the decision.  An indication about … Continue Reading

Amarin Obtains Preliminary Injunction Against FDA Regarding Off-Label and First Amendment Issues

In our prior posts about Amarin Pharma, Inc. v. FDA, we wondered what the Southern District of New York would make of Amarin’s request for an order prohibiting the FDA from taking enforcement actions against it over speech regarding “off-label” uses of its prescription drug, Vascepa.  Although Vascepa is regulated as a drug, equivalent products … Continue Reading

Amarin Pharma v. FDA – More Briefs Filed Regarding Off-Label Promotion And The First Amendment

Our prior  posts  looked at the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit, which raises issues regarding the First Amendment and how it applies to speech by drug and device manufacturers regarding “off-label” uses.  We provided links to amicus briefs by the Pharmaceutical Research and Manufacturers of America and the Washington … Continue Reading

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it applies to speech by drug and device manufacturers regarding “off-label” uses.  As we noted, on June 8, 2015, … Continue Reading

FDA Sued By Drug Manufacturer Over Constitutional Right To Discuss Off-Label Uses

The FDA has long sought to ban manufacturers from promoting off-label uses of approved drugs and medical devices.  In taking the position that manufacturers and their agents cannot promote off-label uses, the FDA suggests they are safeguarding the public from misbranded medical products and ensuring that manufacturers do not circumvent the drug- and device-approval processes. … Continue Reading

21st Century Cures Markup Underway; Offsets Released

Today the House Energy and Commerce Committee is marking up H.R. 6, the 21st Century Cures Act, a high-profile, bipartisan bill that seeks to accelerate the pace of medical cures in the United States through a variety of reforms addressing drug and device development and approval, clinical trial design, research funding, interoperability of health technology, … Continue Reading

Bipartisan Energy & Commerce Committee Leaders Release Updated 21st Century Cures Draft

The bipartisan leadership of the House Energy and Commerce Committee has released their 2015 version of the 21st Century Cures Act, which is intended to bolster medical discovery, treatment development and delivery of treatment to patients. The nearly 200-page legislation is the product of a year-long collaboration between lawmakers and stakeholders.… Continue Reading

FDA Releases Draft Guidance on Acceptance of Medical Device Clinical Data from Studies Conducted Abroad

The Food and Drug Administration (FDA) has issued a notice announcing the availability of a draft guidance document clarifying its acceptance of medical device clinical data from studies conducted in countries other than the United States. The document is intended to provide guidance regarding the 2012 Food and Drug Administration Safety and Innovation Act § 1123, amending Food, Drug & Cosmetic Act § 569B, which codified FDA's policy of accepting scientifically-valid clinical data obtained from non-U.S. clinical studies in support of premarket submissions for medical devices.… Continue Reading

FDA Hosting Workshop on April 1 to Discuss Clinical Outcome Assessments

As mentioned on our Health Industry Washington Watch blog, the FDA will host a public workshop on April 1, 2015 to provide updates on the use of clinical outcome assessments (COAs), as well as to address plans for future development and use of COAs in drug development programs. The workshop, entitled “Clinical Outcomes Assessment Development … Continue Reading

FDA Draft Guidance Addresses Electronic Informed Consent in Clinical Investigations

FDA has issued a draft guidance providing recommendations for clinical investigators, sponsors and institutional review boards on the use of electronic informed consent for FDA-regulated clinical investigations of medical products, including drugs, medical devices and biological products. FDA is accepting comments on the draft guidance until May 8, 2015. In addition, the HHS Office for Human Research Protections (OHRP) is considering whether to adopt the positions and recommendations proposed in this guidance for research regulated under the HHS protection of human subjects regulations and to issue a joint OHRP/FDA guidance document on this topic once the FDA's final guidance document has been developed.… Continue Reading

Public Consultation Examines Potential Confidentiality Issues with New European Clinical Trial Regulations

Since January 21, the European Medicines Agency (EMA) has been holding a public consultation on the new European Clinical Trial Regulations (CTRs), which are intended to streamline the application process for clinical trials and increase the availability of information and results. However, the CTRs have met with some concerns regarding commercial and patient confidentiality. As … Continue Reading

False Advertising Claims & The First Amendment

The U.S. Court of Appeals for the District of Columbia Circuit ruled on January 30th that the Federal Trade Commission can prohibit POM Wonderful LLC from making the advertising claim that its products can help in fighting afflictions and ailments such as heart disease, prostate cancer and erectile dysfunction. The appeals court also decided that POM Wonderful requires the support of one clinical trial before it can make any subsequent claims that its products are effective in fighting disease. POM Wonderful had maintained that its advertisements and claims are protected under the First Amendment, a position that was rejected by the appellate court's decision.… Continue Reading

U.S. Congressional Committees Address Drug And Device Approval

As mentioned on our Health Industry Washington Watch blog, committees in both the House of Representatives and Senate last week addressed the speed at which medical innovations are approved and available for patient use. The House Energy and Commerce Committee’s “21st Century Cures Act” discussion draft, released on January 27, 2015, is a wide-reaching bill … Continue Reading

Proposed Rule Re Submitting Clinical Trial Registration and Results, Including Adverse Event Information, To Database

The National Institutes of Health has released a proposed rule designed to provide clarity on the requirements surrounding the submission of information to, as mandated by the Food and Drug Administration Amendments Act of 2007. Among these requirements is the submission of summary results for clinical trials involving all pharmaceuticals, medical devices and biological products, regardless of whether they have been approved, licensed or cleared by the Food and Drug Administration. The rule also provides timetable restrictions for the registration of a clinical trial and submission of summary results, as well as guidelines for the reporting of adverse events.… Continue Reading

FDA Draft Guidance Encourages Companies to Study Drugs for Treatment of CFS and ME and Provides Roadmap to Approval for this Indication

The FDA recently released draft guidance designed to accelerate the development and review process for drugs intended to treat Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME), a condition for which there is currently no FDA-approved treatment. Though non-binding, the guidance should help drug manufacturers design and execute studies that are more likely to succeed in satisfying the FDA clearance requirements that there be "substantial evidence" of the efficacy of a product and an acceptable risk/benefit profile. The guidance will become finalized following the end of its notice/comment period on May 12, 2014.… Continue Reading

New HHS Federal Research Conflict of Interests Regulations

On September 26, 2011, the U.S. Department of Health and Human Services (“HHS”) issued new regulations governing the disclosure by faculty members and research staff of significant financial interests related to certain federal grants, and the reporting of “financial conflicts of interest” to certain federal agencies by colleges and universities that receive funding for Public … Continue Reading

Increasing Clinical Trial Enrollment; Comments Requested

On January 13, 2009, the FDA published a notice seeking comments on issues related to the enrollment of certain populations in clinical drug trials. This request is related to FDA’s implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA) section 901, which requires the FDA to report to Congress on best practice approaches … Continue Reading

Certifications of Clinical Trial Registry/Results Submissions; Final Guidance

The FDA has released final guidance on “Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007.” The guidance describes the FDA’s current thinking regarding the types of applications and submissions that sponsors, … Continue Reading

Under Construction: The Medicare Clinical Trial Policy

A lesser-known provision in the Medicare Program allows payment for “reasonable and necessary” items or services provided through clinical trials. At the same time, even for traditional reimbursement, the Centers for Medicare & Medicaid Services (CMS) increasingly is demanding evidence of effectiveness in the Medicare population, rather than simply in the general population, to support a … Continue Reading