In particular, Gottlieb is calling for the agency to intervene in cases when brand-name pharmaceutical companies use FDA safety rules in an effort to prevent generic manufacturers from accessing drugs needed for testing to make generic equivalents. "The FDA has an important role to play in making sure that its statutory and regulatory processes are working as intended, and not being manipulated in ways that the FDA and the US Congress did not intend," he said.
The commissioner also indicated that the agency could publish lists of older drugs without generic competitors in order to spur potential new market entries, while discouraging the practice of companies acquiring older therapies and then hiking their prices.
Additionally, Gottlieb aims to speed generic drug approvals by reducing the backlog of applications at the agency, which currently stands at 2640 filings. He also recommended that the FDA take steps to ease the entry of generic versions of complex reference products that lack competition, sometimes due to regulations that make it difficult in some cases for generic drug manufacturers to demonstrate equivalence.
Gottlieb, who was confirmed by the US Senate as FDA commissioner earlier this month, recently highlighted a need for the FDA to play a role in controlling drug prices. For related analysis, see ViewPoints: Trump eschews unpredictability by tapping Gottlieb to head FDA.
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