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On August 2, 2021, the U.S. Food and Drug Administration (“FDA”)  published a final rule amending existing regulations (21 C.F.R. § 201.128 and 21 CFR § 801.4) that describe the types of evidence relevant to determine a drug or device’s intended use under the Food, Drug and Cosmetic Act (“FDCA”).  See 86 Fed. Reg. 41,384–85.

This final rule, which takes effect as of September 1, 2021, withdraws and replaces a final rule that FDA promulgated on January 9, 2017, but which never became effective due to an outcry concerning a problematic knowledge provision that was contrary to the statutory scheme of the FDCA and to physicians’ autonomy to use FDA-approved products in an off-label manner.

Prior to the 2021 final rule, FDA issued a proposed rule on September 23, 2020 that eliminated the 2017 rule’s knowledge provision and was much more aligned with FDCA intent and current FDA policy and practice.  FDA maintains, and we agree, that August 2021 final rule remains largely unchanged from the 2020 proposed language.

The following is a review of some important changes that FDA regulated entities should take note of as they develop and market FDA regulated products:

Continue Reading FDA clarifies evidence and knowledge requirements in intended use final rule

The Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) have been fighting fraudulent and deceptive advertising of health care devices, household cleaners, nutrition supplements, and other health care products promising to protect or mitigate the effects of the virus for pandemic-wary consumers since March 2020. Despite these efforts, false and misleading

The House Energy and Commerce Health Subcommittee voted to approve the following health policy bills on January 18, 2017:

  • H.R. 2026, the Pharmaceutical Information Exchange (PIE) Act. This bill would create a safe harbor that would allow drug and medical device companies to share certain health care economic or scientific information with payers, formularies, and

The federal Food and Drug Administration (FDA) just announced that the Drug Supply Chain Security Act (DSCSA) deadline of July 1, 2015 for dispenser requirements related to capturing and maintaining pedigree information will not be enforced until November 1, 2015. This means dispensers have an additional four months to establish a commercially-viable and operational system that can exchange, capture, and maintain product tracing information for certain prescription drugs. Specifically, on July 6, 2015, the FDA issued a notice announcing the availability of guidance for industry entitled “DSCSA Implementation: Product Tracing Requirements for Dispensers – Compliance Policy” (DSCSA Compliance Policy). The guidance arises from the 2013 DSCSA, which added sections 581 and 582 to the federal Food, Drug, and Cosmetic Act (FD&C Act) and set forth new definitions and requirements for the tracing of products through the pharmaceutical distribution supply chain. The DSCSA requires trading partners (i.e., manufacturers, wholesale distributors, dispensers, and repackagers) to exchange product tracing information when engaging in transactions involving certain prescription drugs. For dispensers, DSCSA requirements for the tracing of products through the pharmaceutical distribution supply chain went into effect on July 1, 2015.
Continue Reading FDA Helps Dispensers Enjoy the Summer with Generous DSCSA Compliance Policy

This post was also written by Jillian W. Riley.

The Food and Drug Administration (FDA) has just announced that it will hold a public hearing March 25 and 26, 2014 to obtain input on the Agency’s current process for reviewing over-the-counter (OTC) drugs. This is a significant advancement in FDA’s long-standing plan to overhaul the OTC drug system. According to the announcement, the Agency’s OTC drug review “needs a critical examination at this juncture to examine whether and how to modernize its processes and regulatory framework.”

Teeing up the importance of the public hearing, Dr. Janet Woodcock, the Director of FDA’s Center for Drug Evaluation and Research (CDER), informed the Wall Street Journal that the Agency was “looking for creative ideas about how to improve the process.”1 According to Dr. Woodcock, “The current system isn’t working well for the public or for us.”  Additional details are available after the jump.

Continue Reading FDA to Overhaul an OTC System That “Isn’t Working”

On November 27, 2013, President Obama signed into law H.R. 3204, the “Drug Quality and Security Act” (the “Act”), bipartisan drug distribution security legislation. Among other things, the sweeping measure: clarifies current federal law and regulatory oversight regarding pharmacy compounding; establishes a uniform, national drug tracking and tracing framework; mandates national licensure standards for wholesale distributors and third-party logistics providers; and preempts state product tracing requirements. The following is an overview of the Act and highlights of initial FDA implementation guidance.
Continue Reading Drug Distribution Security Legislation Signed into Law

The Food and Drug Administration (FDA) has announced the availability of a new draft guidance document entitled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” The draft guidance identifies cybersecurity issues that medical device manufacturers should consider in preparing premarket submissions for medical devices – including Premarket Notifications (510(k)), Premarket Approval Applications

The U.S. House of Representatives has approved by voice vote H.R. 1919, Safeguarding America’s Pharmaceuticals Act of 2013. H.R. 1919 is a bipartisan bill intended to improve drug distribution security and protect against counterfeit pharmaceuticals. According to the bill’s sponsor, Rep. Bob Latta (R-Ohio), the bill would replace an unworkable patchwork of state laws

Key members of the Senate Health, Education, Labor, and Pensions Committee have released a bipartisan draft legislative proposal intended to improve drug distribution security. The legislation addresses, among other things: lot-level product tracing requirements for “downstream” pharmaceutical supply chain members (drug manufacturers, repackagers, wholesale distributors, and dispensers); a requirement that manufacturers serialize prescription drugs

This post was also written by Erin A. Janssen.

The FDA and representatives from the medical device industry reportedly reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program, according to an announcement released February 1, 2012 on the FDA’s website. FDA claims the agreement

This post was also written by Erin Janssen. With only days to spare in 2011, and after two years of anticipation, FDA’s Internet and social media policy is finally starting to emerge. On December 27, 2011, FDA announced the availability of draft guidance entitled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs

On July 27, 2011, the Food and Drug Administration (“FDA” or “Agency”) released a draft guidance document for manufacturers regarding when to submit a premarket notification submission (510(k)) for changes or modifications made to a previously cleared medical device. When final, this guidance will supersede a guidance document that FDA issued in 1997 (Deciding

In April 2010, Reed Smith provided an extensive analysis of the recently-enacted health reform legislation, H.R. 3590, the Patient Protection and Affordable Care Act (PPACA), as amended by H.R. 4872, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act). Together, these sweeping measures expand access to health insurance (including subsidies, mandates, and market reforms); reduce health care spending (particularly in the Medicare program); expand federal fraud and abuse authorities and transparency requirements; impose new taxes and fees on health industry sectors; and institute a variety of other health policy reforms.

In this analysis, we concentrate on those provisions in the new law that will affect life sciences entities: pharmaceutical, device, and biologics manufacturers. These include significant revisions to the Medicaid drug rebate program and the Medicare Part D prescription drug program; an expansion of the Public Health Service Section 340B drug discount program; the imposition of substantial new industry fees and excise taxes; creation of an abbreviated approval pathway for follow-on biologics; and sweeping new reporting and disclosure requirements affecting all manufacturers regarding their relationships with physicians and teaching hospitals, among other changes.

Many of the new provisions require the Secretary of the Department of Health and Human Services (HHS) to issue implementing regulations. We have referenced notices that have been published already, and we will be reporting on additional developments in the coming months.
Continue Reading Reed Smith Health Care Reform Review: The Affordable Care Act – Analysis and Implications for Drug, Device and Biotech Manufacturers

This post was also written by Areta Kupchyk.

On May 11, 2010, the Food and Drug Administration (FDA) launched a new initiative – the “Bad Ad Program” – designed to educate health care practitioners about their role in ensuring that prescription drug advertising and promotion is truthful, and not misleading. With the launch of