Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and whether it comports with First Amendment free speech principles—persist. The FDA has announced a two-day public hearing on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” In-person … Continue Reading
We have been closely following Amarin Pharm, Inc. v. FDA with respect to the preliminary injunction granted by the Southern District of New York that prohibited the FDA from taking action against Amarin over truthful, non-misleading “off-label” statements about its prescription drug Vascepa. We’ve also been following the similar Pacira Pharm., Inc. v. FDA case, which … Continue Reading
The Pacira Pharmaceutical Inc. v. FDA lawsuit has been a frequent topic of discussion on the blog, and now, in breaking news, the case has been settled. Pacira will be receiving essentially everything it wanted in a “favorable resolution,” and the FDA is formally withdrawing its warning letter that attempted a retroactive reduction in the … Continue Reading
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
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
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
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
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
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
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
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
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
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
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
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 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
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
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
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
The National Institutes of Health has released a proposed rule designed to provide clarity on the requirements surrounding the submission of information to ClinicalTrials.gov, 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
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
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
In an article entitled, "The Legal Duties Of Clinical Trial Sponsors," published by Law360.com on July 11, 2011, Reed Smith attorney Kevin Lohman addresses the risks involved in human clinical trials and the responsibilities between the clinical study investigator and the manufacturer/sponsor.… Continue Reading
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
