Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access; Public Meeting

In the Federal Register (FR) of June 22, 2017 (82 FR 28493), FDA published a notice of public meeting with a 60-day comment period to request comments on the appropriate balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs.  After receiving extension requests to allow interested persons additional time to comment, FDA has extended the comment period. Please submit electronic or written comments to Docket FDA-2017-N-3615 by November 17, 2017. Further information can be found in the extension of comment period notice.

Summary:

“Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access” was a meeting held on July 18, 2017 to provide the public an opportunity to submit comments concerning administration of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to help ensure the intended balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs is maintained. Further information, including questions for stakeholder input, can be found in the public meeting notice. Public comments will be accepted through November 17, 2017 at the Public Docket, FDA-2017-N-3615.

Date:

July 18, 2017

Time:

9:00 a.m. to 5:00 p.m.

Location:

FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
Great Room (Rm. 1503)
Silver Spring, MD 20993
Public Meetings at FDA White Oak Campus

Meeting Materials:

• Opening Remarks by Dr. Gottlieb
• Meeting Transcript (PDF - 9 MB)
• Final Agenda (PDF - 50KB)
• Federal Register Notice of Public Meeting
• Federal Register Notice of Comment Period Extension

Meeting Recordings:

• Part 1
• Part 2
• Part 3
• Part 4

Presentations:

Additional presentations have been submitted by some presenters to the Public Docket, FDA-2017-N-3615

• Abuse of the FDA Regulatory Process And Possible Solutions (PDF - 619KB)
  David Balto, Law Offices of David Balto
• Small Revenue Concentrated Markets, Expedited Reviews, and Incentives to Ensure A Balance between Innovation and Access (PDF - 891KB)
  Ernst Berndt, MIT Sloan School and the National Bureau of Economic Research
• Striking the Balance: Opportunities to Promote Drug Competition (PDF - 545KB)
  Alex Brill, Matrix Global Advisors
• Four Proposals To Enhance Generic Competition (PDF - 2MB)
  Michael Carrier, Rutgers Law School
• Perspectives on Hatch-Waxman (PDF - 376KB)
  Steve Caltrider, Eli Lilly and Company
• Liposomal Doxorubicin Call for Clarity (PDF - 624KB)
  Kenneth Kleinhelz, Cytori Therapeutics, Inc.
• FDA hearing on Hatch-Waxman Act and drug pricing (PDF - 33KB)
  James Love, Knowledge Ecology International
• Patients for Affordable Drugs (PDF - 1MB)
  David Mitchell, Patients for Affordable Drugs
• Pharmaceutical quality is an area where Hatch-Waxman Amendments have had a favorable impact on the development of both brand and generic products (PDF - 179KB)
  James Polli, University of Maryland School of Pharmacy
• FDA evaluation/approval process for older medications including DESI drugs (PDF - 64KB)
  Wayne Russell, Premier HC Solutions
• Ensuring Timely Availability and Use of Low-Cost, High-Quality Generic Drugs (PDF - 238KB)
  Ameet Sarpatwari, Brigham and Women’s Hospital
• The Campaign for Sustainable RX Pricing; Hatch-Waxman Meeting July 2017 (PDF - 593KB)
  Rodney Whitlock, ML Strategies, LLC

For Further Information, Contact:

Philip Bonforte
Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 75, Rm. 1668, Silver Spring, MD 20993
Phone: 240-402-6980
Email: GenericDrugPolicy@fda.hhs.gov

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