May 26, 2017
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – Two weeks after his confirmation, new U.S. Food and Drug Administration Commissioner Scott Gottlieb is already hard at work looking to hire additional staff and addressing ways to prevent speculator pharma companies from jacking up prices on drugs for which there is no generic equivalent.
During a meeting with an appropriations subcommittee in the U.S. House of Representatives, Gottlieb said the FDA is no longer under a federal hiring freeze, according to a reports in RAPS, Regulatory Affairs Professionals Society. Shortly after being sworn in as president, Donald Trump enacted a hiring freeze on new federal employees, with some exceptions–a move that impacted FDA hiring plans set into motion by former Commissioner Robert Califf last year. In June 2016, Califf posted a blog touting the mission of the regulatory agency and the need to hire additional staff to meet those needs. The FDA was looking to fill about 1,000 employees. Now it looks like the hiring can begin again. However, how quickly hiring will be ramped up at the FDA is not yet known. There are a number of open positions at the FDA listed on the USA Jobs portal.
But, it wasn’t just jobs that Gottlieb addressed during his testimony. He also discussed the FDA’s plans to address a way to increase drug competition and avoid a rise of pharma speculators such as Martin Shkreli, who acquired the toxoplasmosis drug Daraprim, which had no generic equivalent, and increased the price by 5,000 percent. Gottlieb said he will soon reveal a plan of action to improve the generic approval process to increase completion and prevent future Shkrelis.
“We do have situations where speculators, for lack of a better word, can come in and buy a low volume generic, jack up the price knowing that it will take potentially years for generic competition to come on to the market so they have that sort of an exclusivity period,” Gottlieb said in his testimony, according to a report in Endpoints.
While Gottlieb said he will unveil his plans later, he did provide a three-pronged outline of what he intends. His initiatives include increasing efficiency of the FDA’s generic drug review process and eliminating a backlog of generic applications; improve the generic drug approval process; and “curtail gaming by industry of our regulations which can extend monopoly periods beyond the time frame Congress intended, hindering competition.”
Gottlieb pointed to the federal REMS program (risk evaluation and mitigation strategies), which he said has been used to slow generic competition, Endpoints noted. Gottlieb said streamlining the generic approval process is something he’s called for in past years. His suggestion was to eliminate the requirement that generic and brand manufactures share a single safe use system. Endpoints noted that generic manufacturers have had to resort to taking legal action against brand manufacturers that refused to negotiate a shared safety system. That refusal was one way to protect market share.
In addition to changes in generic drug approval, Gottlieb also told lawmakers that he wants to see the Breakthrough Therapy Designation embraced throughout the FDA. He noted the oncology group at the FDA has been successful with this and wants to see it used throughout.
Gottlieb did take some heat from federal lawmakers over some of the items in President Trump’s proposed budget, including an increase in user fees at the FDA. The House committee members did not seem supportive of the plan. However, Gottlieb told the legislators he was not involved in those budget negotiations as he was only confirmed earlier this month.
