FDA Urged to Address Industry Practices Hindering Generic Drug Competition

September 19, 2017

On September 18, ASCO submitted comments to the Food and Drug Administration (FDA) in response to a request for feedback on administering the 1984 Hatch-Waxman Amendments (formally the Drug Price Competition and Patent Term Restoration Act), which first established a regulatory pathway for the entry of generic drugs to the marketplace.

In the comment letter, ASCO affirmed its continued support for the law’s goals of balancing innovation in drug development and accelerating the public’s access to lower cost alternatives to innovator drugs and stated that “any solutions should promote affordable drug prices and foster innovation.” However, as ASCO points out in its comment letter, the Hatch-Waxman Amendments have created a number of unintended practices that impede progress of those goals.

For example, pharmaceutical companies use the practice of product hopping to introduce reformulations of their branded product that offer little or no therapeutic advantage over the original product to delay market-entry date for generics. Companies also use the practice of evergreening to patent new drugs that are actually old drugs with slight modifications.

To address these issues, ASCO recommends FDA approve reformulated products and extend patents only when the new therapy provides clinically meaningful benefits to patients. ASCO also recommends FDA ensure that clinical trial developers use clinically meaningful outcomes instead of small, incremental improvements. In the letter, ASCO President Bruce E. Johnson, MD, FASCO, states “Ultimately, ASCO believes there should be a real and consistent relationship between a drug’s benefits for patients and its cost. While FDA does not have jurisdiction over the price of drugs, there is a definite link between drug price and availability of generic drug competition. Use of the clinically meaningful standard for product reformulations may help the FDA promote greater opportunities for generic competition, which may make it easier for the FDA to promote generic competition.”

ASCO also recommends FDA address the practice of pay for delay, where drug manufacturers pay other companies not to introduce lower cost alternatives. This practice is estimated to cost consumers $3.5 billion in higher drug costs each year.

Read the full comment letter.

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