Drugs

Diverse Views on Waxman-Hatch Balance

David McFarland

— 1 min read
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The FDA request for stakeholder views on ensuring a balance between innovation and access in the Waxman-Hatch amendments has brought diverse views. In its response, Vifor Pharma says that generic forms of non-biological complex drugs (NBCDs) should not be approved via the ANDA pathway. It asks the agency to acknowledge that: 

  •          NBCDs represent a category of complex drugs for which the ANDA pathway is not appropriate;
  •          a pathway aimed at establishing the similarity of follow-on NBCDs through clinical safety and/or efficacy studies, as necessary, would better ensure patient safety and drug efficacy; and
  •          the biosimilars approval pathway provides a model for how the similarity of follow-on NBCDs could be demonstrated.

The Biotechnology Innovation Organization recommends that FDA allow the many generic drug program reforms it has recently announced to go into and through the marketplace and evaluate their impact before making any further changes to Waxman-Hatch.

The Pew Charitable Trusts raises several issues for consideration, including drug company use of Risk Evaluation and Mitigation Strategies (REMS) in an effort to block competition, abuses of the citizen petition process, the potential for FDA’s unapproved drugs initiative to drive up costs, public access to market information, and safety and quality issues.

In its letter, the United States Pharmacopeia says it supports the agency’s efforts to increase patient access to affordable quality generic medicines, and believes development of public standards is one important part of the solution to this effort.

Finally, Public Citizen says the U.S. is in desperate need of strong action to lower prescription drug prices and expand access to medicines. “While there are remedies under existing law that agencies can take to lower prescription drug prices and expand access to medicine,” it says, “the nature of the problem requires robust legislative reform. In our view, the root problem of high U.S. drug prices is the monopoly power of the pharmaceutical industry. Government-granted monopolies provide incentive for prescription drug corporations to engage in a range of abusive behaviors, from fraudulent reimbursement schemes and price gouging, to efforts to inappropriately extend monopolies through evergreening, REMS abuse, and pay-for-delay deals.”

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