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FDA Approves Marijuana-Derived, CBD-Containing Drug Epidiolex to Treat Certain Epilepsy-Associated Seizures

On June 25, 2018, the U.S. Food and Drug Administration approved Epidiolex, an orally administered drug derived from the marijuana plant, Cannabis sativa. The drug is approved for use for patients two years and older, for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, both of which are rare and severe forms of epilepsy. It is the first drug that FDA has approved for Dravet patients.…

FDA Provides Guidance on Postmarketing Safety Reporting for Combination Products

On March 21, 2018, the Food and Drug Administration (FDA) published two guidance documents addressing postmarketing safety reporting requirements (PMSR) for combination products.  The FDA had previously issued a Final Rule on PMSR for combination products on December 20, 2016 (PMSR Final Rule).

By way of background, combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. Because PMSR regulations for medical products in different categories are individualized (for example, PMSR are different for drugs than they are for medical devices and biological products), the two …

FDA Amends Regulations for Acceptance of Data from Foreign and Domestic Investigation for Medical Devices

On February 21, 2018, the Food and Drug Administration (FDA) published a Final Rule, amending its regulations on acceptance of data from investigations for medical devices that are performed outside of the United States as well as modifying certain regulations applicable to data from US-sited investigations. The Final Rule does not go into effect until February 21, 2019 – a full year after promulgation.  The FDA also issued guidance in the form of Frequently Asked Questions (FAQ) addressing the new regulations.  In the FAQ document, the FDA explained its …

FDA Issues New Compounding Guidance

In January 2018, the U.S. Food & Drug Administration (FDA) published two guidance documents on Compounded Drug Products That Are Essentially Copies Of Approved Drug Products under Section 503A and Section 503B of the Federal Food, Drug, and Cosmetic Act (the Act). As emphasized in a recent U.S. Department of Justice policy memorandum, FDA noted that its guidance documents do not establish legally enforceable responsibilities and, instead should be viewed only as agency recommendations, unless specific regulatory or statutory requirements are cited.

FDA Issues Guidance on Hurricane Readiness for Medical Devices

The U.S. Food & Drug Administration (FDA) has issued important guidance on how to prepare for hurricanes when dependent on medical devices.  FDA stresses that during hurricanes and other emergency situations, medical devices may be exposed to fluctuating power, contaminants, or unusual levels of heat or humidity. The guidance links to pages providing information on the use of medical devices during and during emergency situations and afterwards, including:

Ninth Circuit Relies on Escobar to Revive False Claims Act Suit Against Pharmaceutical Manufacturer

On July 7, 2017, the U.S. Court of Appeals for the Ninth Circuit reversed a federal district court’s dismissal of a False Claims Act (FCA) whistleblower suit in United States ex rel. Campie v. Gilead Sciences, explaining that the district court did not have “the benefit of” the Supreme Court’s 2016 decision in Escobar at the time the suit was dismissed for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6).…

Supreme Court Decision Allows Faster Marketing of Biosimilars

On Monday, June 12, 2017, the United States Supreme Court in a unanimous decision held that manufacturers making biosimilars of biologic drugs did not have to wait until after gaining federal approval of the biosimilar to notify the manufacturer of biologic reference products (Sponsor) that they intend to commercially market a biosimilar drug. The Court’s decision addresses two cases in the same opinion: Sandoz v. Amgen and Amgen v. Sandoz. …

FDA’s Center for Devices and Radiological Health Issues Strategic Priorities

The Center for Devices and Radiological Health (CDRH) recently issued strategic priorities for 2016-17.  The primary strategic priorities include:

  1.  Establish a National Evaluation System for Medical Devices (NEST), to efficiently harness real-world “evidence of clinical experience.” Actions taken to date include, among others:
  • A multi-stakeholder Planning Board and the Medical Device Registry Task Force issued a series of reports that outline the organizational structure and infrastructure for the NEST Coordinating Center, in February 2015, April 2016, August 2015, and September 2016.
  • The FDA awarded $3

FDA Delays Intended Use Regulations

The U.S. Food and Drug Administration (FDA) announced that it was delaying until March 19, 2018, a Final Rule that has been viewed as having a chilling effect on scientific speech in attempting to broaden FDA’s authority to find an “intended use” for an approved or cleared medical product.  FDA extended the effective date to allow additional public comments after a petition filed on behalf of various industry groups challenged the Final Rule (dockets FDA-2011-P-0512, FDA-2013-P-1079, FDA-2015-N-2002, and FDA-2016-N-1149).

In the Final Rule, FDA had amended the intended use …

US and EU Agreement Allows Mutual Recognition of GMP Inspections

On March 2, 2017, U.S. Food and Drug Administration (FDA) announced that the United States had reached an agreement with the European Union (EU) that will allow FDA and EU regulators to use each other’s good manufacturing practice (GMP) inspections of pharmaceutical manufacturing facilities.  The agreement, entered into after several years of joint collaboration and evaluation, should help to avoid duplication of drug inspections and lower inspection costs. The FDA’s authority to enter into the agreement is derived from the Food and Drug Administration Safety and Innovation Act, which allows …

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