On Tuesday, the FDA held a public meeting titled “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.”
On Tuesday, the FDA held a public meeting titled “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.” The meeting provided an opportunity for the public to submit comments concerning the ways in which the FDA administers the Hatch-Waxman Amendments with respect to prioritizing the approval of generic drugs.
The Hatch-Waxman Act (formally titled The Drug Price Competition and Patent Term Restoration Act) was first implemented in 1984. The act was intended to expedite the approval of generic drugs, provide periods of patent exclusivity, and streamline the litigation process surrounding generic drugs. The FDA called this week’s public meeting to hear comments on how the FDA can help establish a balance between encouraging innovation and facilitating the availability of lower-cost generic drugs for patients.
FDA Commissioner Scott Gottlieb, MD, opened the meeting by noting that too many patients are unable to afford necessary drugs. “FDA doesn’t have a direct role in how drugs are priced,” Gottlieb said, “but at FDA, we do play a key, if indirect, role in the eventual cost of medicines.” He went on to explain that the FDA will seek to reduce prices by ensuring that the agency is efficient, predictable, and science-based with respect to its regulatory requirements, and that it will prioritize price competition among drugs.
Gottlieb also announced that the FDA is developing 2 new documents that will help streamline the Abbreviated New Drug Application (ANDA) process. First, the agency will issue a “Good ANDA Assessment Practices” Manual of Policies and Procedures (MAPP). This document will outline approaches to streamlining the ANDA review process. Second, the FDA will issue a “Good ANDA Submission Practices” guidance document that will detail common deficiencies that the agency sees in applications, and will provide advice on how to avoid these problems.
Following Gottlieb’s remarks, members of the public addressed a panel comprising representatives from the FDA and the Federal Trade Commission. Individuals representing academic and research, payer and provider, pharmaceutical product development, and patient and consumer perspectives provided comments to the panel.
Across the variety of stakeholder perspectives, some common themes and concerns emerged:
In closing the meeting, Keith Flanagan of the FDA’s Office of Generic Drugs and the Center for Drug Evaluation and Research, said that it will take the agency time to digest the information that it has received from the public, and that it will leverage the insights gained through public comment. In addition to considering presentations made at the meeting, the agency will also review comments made on the its docket.
Among those who have already submitted written comments to the docket are former Representative Henry Waxman, one of the co-sponsors of the original Hatch-Waxman legislation. Waxman's remarks include a report, “Getting to the Root of High Prescription Drug Prices,” that describes drivers of high prescription drug costs and potential actions that could be taken to address those costs. Among Waxman’s recommendations are that the FDA:
Electronic comments may be submitted on docket number FDA-2017-N-3615 until September 18, 2017.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.