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26 October 2018Americas

FDA improves generic approval rate under Trump: report

The US Food and Drug Administration’s (FDA) generic drug approval rate has increased at a “rapid rate” since January 2017, despite the number of branded drug patent expirations declining during this period.

This was one of the findings revealed in “ The Administration’s FDA Reforms and Reduced Biopharmaceutical Drug Prices” report, released yesterday, October 25, by the US Council of Economic Advisers, a government agency.

“Current FDA reforms are lowering entry barriers for new pharmaceutical drugs, and this partly accounts for the slower growth of drug prices,” the report explained. The reforms reportedly stem from Trump’s “deregulatory agenda”.

According to the council, the report shows that President Donald Trump’s policies have helped to decrease the prices of prescription drugs for American patients.

On average, the FDA has approved 17% more generic drugs each month since January 2017 than it had done in the previous 20 months.

Also, relative annual price growth for prescription drugs has slowed since January 2017, and the lower prices resulting from new generic drugs have saved consumers a total of $26 billion between then and July 2018.

The report also noted that generally, the more manufacturers producing a generic drug, the lower the price of that drug.

“New drugs reduce the price of better health from prohibitive levels to patented price levels,” it said. “For the new drugs approved since January 2017, we find that the price reductions have generated annualised gains to consumers of $43 billion in 2018.”

A White House press release said that Trump has launched a series of reforms to facilitate better price competition, by streamlining the drug application and review process in a way that lowers barriers to entry.

It added that, in May 2018, Trump introduced the American Patients First Blueprint in efforts to bring the price of pharmaceutical products down. The Blueprint offers strategies to help patients address rising drug costs.

The FDA has also been actively implementing policies and reforms to enhance generic competition and decrease drug prices.

Earlier this month, the administration released guidance intended to advance the development of generic versions of complex medical drugs, in addition to pledging to end the “gaming” of the approval system.

The FDA has also recently launched a biosimilars action plan: a four-part strategy aimed at strengthening sales of biosimilars.

And, in August, the FDA approved the first generic drug to receive a competitive generic therapy (CGT) designation. CGT designation was designed to speed up the development and review of a generic drug for products that lack competition.

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