President-elect Donald Trump could significantly affect the Food and Drug Administration's oversight of the drug industry, according to John LaMattina, former president of Pfizer Global Research and Development.
In a recent column for Forbes, Mr. LaMattina shared his thoughts on how the FDA may change after Mr. Trump takes office.
1. Lowering the bar for generic drug approvals. Mr. LaMattina said the Trump administration may loosen the approval process for generic drugs to more quickly work through the backlog of drug applications at the FDA. An easier approval process would also provide more generic alternatives for brand name drugs on the market.
2. The eteplirsen example. In September, the FDA controversially approved Sarepta Therapeutics' muscular therapy drug eteplirsen after FDA staff members said there was not enough evidence to support the drug's efficacy. Mr. LaMattina predicts the agency will approve more orphan drugs, like eteplirsen, that treat a small amount of patients with rare diseases who have no other treatment alternatives.
3. Easing of off-label use restrictions. Mr. LaMattina believes the current restrictions on the marketing of off-label use of approved drugs will be lifted under Mr. Trump's presidency. The publication of clinical trials proving the benefit of a drug in a new indication will be sufficient proof to allow drugmakers and devicemakers to discuss the new use of the product with clinicians, he said.
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