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FDA Announces Upcoming ANDA Guidance at Hatch-Waxman Public Meeting


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:

  • Generic drugs serve the public interest
  • Rewards for innovation must be balanced with patient access
  • Some barriers to generic products lie outside the remand of the FDA, and may require lawmakers to take action
  • Citizen petitions should not be used to delay the entry of generic products
  • Risk Evaluation and Mitigation Strategies, or REMS, have high value, but can be used inappropriately to block generics from market entry; FDA should exercise its shared requirement waiver authority when appropriate to remedy this issue
  • The Patent Trial and Appeal Board must not facilitate “pay-to-delay” tactics
  • 4-letter suffixes for biosimilars could prove confusing for physicians and pharmacists, and rules for clarifying differences among products should be established
  • Generic drugs can begin to cause price erosion at just 3 or 4 products in a class
  • Reference product manufacturers should not be able to refuse to provide samples to generics manufacturers (innovators, for their part, cited a fear of liability as a reason that they did not make their products available)
  • FDA could preempt state laws concerning biosimilar substitution for interchangeable biologics

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:

  • Commit resources to ensure prompt, enhanced FDA review of applications
  • Commit resources to finalize agency guidance on topics including biosimilar interchangeability, and support review and approval to spur competition among biologics
  • Require that reference drug sponsors supply their products to generic and biosimilar manufacturers
  • Require reference manufacturers to disclose all patents covering their products on which a biosimilar or generic manufacturer might infringe when developing a competitive product
  • Identify FDA review practices that would foster the approval of second and third generics and biosimilars for specific reference products
  • Monitor the drug market to identify conditions that could lead to shortages or price increases
  • Permit importation when there exists a single source of an off-patent drug that experiences significant increases in price

Electronic comments may be submitted on docket number FDA-2017-N-3615 until September 18, 2017.

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