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Kathleen M. Sanzo, Jacqueline R. Berman
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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS

Ph.D.s Running the Bases: Free Agency in the Life Sciences Industry

By Kathleen M. Sanzo
// February 01, 2023
Big changes may be on the way for the life sciences industry, especially in the pharma segment, resulting from the Federal Trade Commission’s (FTC’s) proposed rule to ban employers from entering into and using noncompete provisions in employment contracts.
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Topics: Enforcement

FDA Embraces Alternative Tools for Inspecting Facilities

By Kathleen M. Sanzo and Angela Silva
// October 20, 2022
On October 17, 2022, the US Food and Drug Administration (FDA) implemented revisions to two of its compliance policy guides (CPGs). CPGs are intended to advise FDA staff as to the agency's strategy when assessing and enforcing industry compliance. They typically establish FDA policy and interpretation where there is a need for clarification or to address other issues not covered by existing FDA laws, regulations, or guidance.
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Topics: FDA, Manufacturing

Executive Order Outlines New Federal Biotechnology/Manufacturing Goals

By Jacqueline R. Berman and Kathleen M. Sanzo
// September 16, 2022
President Joseph Biden issued an “Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy” (EO) on September 12. Under this EO, the president aims to “advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security” through a multipronged and collaborative approach.
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Topics: Biologics, Drugs, Manufacturing

One License to Unite Them All: FDA Proposes National Standards for Wholesale Distributors and Third-Party Logistic Providers

By Jacqueline R. Berman , Alexandre Gapihan , and Angela Silva
// May 25, 2022
The US Food and Drug Administration (FDA) has issued a proposed rule—“National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers” (Proposed Rule)—pursuant to FDA’s obligations under the Drug Supply Chain Security Act (DSCSA or the Act) that, when finalized, would require all US wholesale drug distributors (WDDs) and third-party logistic providers (3PLs) to be licensed according to a national standard.
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Topics: FDA, Rulemaking, State Laws

FDA’s OGD Publishes Guidance Documents to Hasten Market Entry of Generic Drugs

By Rebecca L. Dandeker and Jacqueline R. Berman
// February 23, 2022
While the Biden administration and US Congress continue to debate ways to address perceived prescription drug pricing concerns, the Food and Drug Administration (FDA) is taking action. Under its Drug Competition Action Plan (DCAP), administered by the Office of Generic Drugs (OGD), FDA has published approximately 24 guidance documents since 2017, directing industry stakeholders on how to develop, prepare, and submit abbreviated new drug applications (ANDAs), so that generic drugs can obtain timely FDA approval and more quickly reach the market. In January 2022, FDA published three more guidance documents in the DCAP series.
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Topics: Drugs, FDA, Generic Drugs, Guidance

Dr. Robert Califf Confirmed to Fill FDA Commissioner Position

By Kathleen M. Sanzo , Jacqueline R. Berman , and Maria Kalousi-Tatum
// February 16, 2022
The US Senate voted on February 15 to confirm Dr. Robert M. Califf as the next commissioner of the US Food and Drug Administration (FDA), a position that has been filled since April 2021 by acting commissioner Dr. Janet Woodcock.
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Topics: FDA

Monograph Soup: The ABCs & XYZs for OTCs on Formal Meetings with FDA

By Jacqueline R. Berman , Kathleen M. Sanzo , and Nikita S. Bhojani
// February 14, 2022
The US Food and Drug Administration (FDA) on February 1 issued a draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs” (Meeting Guidance), that specifies the procedures and principles for meetings between FDA and meeting requestors.
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Topics: FDA, OTC

FDA Finalizes Guidance on Gene Therapy Orphan Sameness, but Questions Remain

By Jacqueline R. Berman
// October 08, 2021
While it may feel like FDA’s attention has been focused on COVID-19 for nearly two years, as we have written about in a previous blog post, FDA is looking to the future, and particularly, one that signals exciting prospects for biotechnology products, including cell and gene therapies. This is mirrored by the increasing financial strength of the biotechnology industry. The Alliance for Regenerative Medicine reports that regenerative medicine and advanced therapy financing soared during the first half of 2021, resulting in the strongest half year to date, and reached 71% of 2020 full year levels. Moreover, the Alliance reports that there are now more than 1,200 companies worldwide developing advanced biotechnology products and an anticipated 18 global regulatory approval decisions this year. Also, 243 regenerative and advanced therapy phase 3 trials were ongoing at the time of the Alliance’s report.
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Topics: FDA, Gene Therapy

A Closer Look at Accelerated Approval and Confirmatory Trials

By Jacqueline R. Berman
// September 29, 2021
The accelerated approval pathway (i.e., the pathway that permits FDA to rely on surrogate or intermediate endpoints for the approval of a drug for serious conditions with unmet medical needs) has proven to be an important tool to provide patients with access to promising products. By example, as of June 2021, the Center for Drug Evaluation and Research approved 269 drug and biologic products via accelerated approval. This does not include Center for Biologics Evaluation and Research approvals, which, as reported in the New England Journal of Medicine, has granted more than 155 accelerated approvals for oncology products alone.
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Topics: Clinical Trials, Drugs, FDA

Tracking Back to Track and Trace: Additional Guidance on Compliance with the DSCSA

By Alexandre Gapihan and Jacqueline R. Berman
// September 20, 2021
Earlier in the summer, the FDA issued a quartet of guidance documents setting forth the Agency’s plan for implementing requirements under the Drug Supply Chain Security Act (DSCSA). The DSCSA directs FDA to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. It also requires that FDA establish national licensure standards for wholesale distributors and third-party logistics providers and establishes requirements for these entities to issue annual reports to FDA. Taken as a whole, these new guidances clarify FDA’s expectations for stakeholders to comply with the law to achieve a safer, more secure, and more trusted drug supply chain.
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Topics: Drugs, FDA
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