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FDA chief clarifies what to expect for website outing system-gamers

Food and Drug Administration Commissioner Scott Gottlieb provided more clarity about the types of information his agency will disclose on a public website about brand-name drug manufacturers that have tried to block generic competitors.

Gottlieb is hoping that by publicly posting the information online, innovator drugmakers will be deterred from trying to game the system.

The website, which is expected to be unveiled May 17, will include details from 150 inquiries from generic drug manufacturers that have sought the agency's help after being blocked from obtaining sample doses of brand-name medicines needed to conduct bioequivalence studies for U.S. approval.

"We are going to retrospectively make available situations where companies have petitioned us to see why they can't get access to the doses they need," Gottlieb told reporters during a May 15 media briefing in Washington hosted by the Alliance for Health Policy and APCO Worldwide.

He said those 150 inquiries involved about 50 different brand-name medicines.

Gottlieb noted that some of those inquiries involved grievances about the same innovator drug — with one product even receiving 10 complaints against it.

"That suggests there's an obstacle," the FDA commissioner said.

"Branded companies are on notice that there will be a website at FDA that's going to identify when multiple generic entrants are having trouble getting access to their physical samples," Gottlieb said.

He reiterated that he was "not looking to shame drug companies" — repeating what he told reporters a day earlier at a briefing at the U.S. Department of Health and Human Services in Washington. "I'm identifying the problem."

The website will not include the identities of the generic companies that sent the 150 inquiries to the FDA, Gottlieb said.

The FDA commissioner acknowledged that he had on earlier occasions talked about posting 150 letters involving brand-name companies. But he clarified that the agency has sent about 20 "affirmative" regulatory letters to innovator companies in response to the 150 generic manufacturer inquiries.

In those 20 letters, the FDA has told the brand-name drugmakers that the agency has reviewed the protocols of the generic companies and they met the standards of the innovator's required safety programs, known as risk evaluation and mitigation strategy plans.

The website will disclose if the FDA has sent a branded company one of those affirmative regulatory letters, Gottlieb said. He said the agency plans to post a template of the letter on its new website.

"It's a pretty standard letter," Gottlieb said.

The FDA chief noted that the agency had hoped to have the website up sooner, but it had "taken longer than we wanted to work through the legal issues of disclosing that information."

Gottlieb first acknowledged he was considering launching the website last summer.

He said there are some drugs from the 150 inquiries "that will be quite interesting to you."

"Some of them we would have thought had generic competition by some big drugmakers," Gottlieb said, adding that some of those medicines had five or 10 inquiries against them.

"So something is going on," he said.