Cheaper Drug Access Faces Many Roadblocks, Critics Tell FDA


FDA Commissioner Scott Gottlieb recently announced steps the agency is considering taking to encourage competition in the pharmaceutical marketplace.

Those steps, announced at a July 18 public meeting, include streamlining the generic drug review process and potentially making public letters the FDA sends to generic drug companies confirming that their use of a sample of a branded drug for purposes of demonstrating bioequivalence wouldn’t violate the branded drug’s risk evaluation and mitigation strategies (REMS). Brand drug companies sometimes use REMS safety requirements to justify holding back samples generics need to test to get regulatory approval for their products.

But some meeting participants told the FDA it must do more.

The FDA should also add REMS patents to the categories of patents ineligible for listing in the Food and Drug Administration’s Orange Book, law professor Michael A. Carrier said. Carrier is a professor at Rutgers Law School and co-director of the Rutgers Institute for Information Policy and Law in Camden, N.J.

The Orange Book is a list of patents brand-name companies claim cover their drug products and often assert to block generic entry.

Carrier also suggested that the FDA publish a list of citizen petitions filed by drug companies. Through citizen petitions, brand-name drug companies often ask the FDA to delay approving pending generic drug applications over safety concerns.

But some petitions don’t actually raise legitimate drug safety concerns and wind up delaying generic drug entry.

“Let’s see a list,” Carrier said. “That would be very helpful.”

Other meeting participants suggested the FDA should take a look at whether the alternative patent challenge proceedings at the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board could be hindering generic drug entry as well as whether certain patent exclusivities—such as the additional exclusivities awarded to orphan drugs—are also stifling competition. The FDA’s orphan drug designation, intended for drugs that treat rare conditions and diseases affecting fewer than 200,000 people in the U.S., gives special incentives to manufacturers, including tax credits, research and development funding, reduced user fees, and seven years of marketing exclusivity upon approval.

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