USFDA plans to ease market entry of generic drugs


Mumbai: The US Food and Drug Administration (FDA) is working to lift certain barriers that delay entry of generic drugs into the market, as part its efforts to provide affordable medicines to patients, said FDA commissioner Scott Gottlieb in an official blog on Wednesday.

The move is likely to benefit Indian generic drug makers that supply a large chuck of their products to the US market. For leading pharmaceutical companies like Sun Pharmaceutical Industries Ltd, Dr. Reddy’s Laboratories Ltd and Lupin Ltd, the US accounts for nearly half of the total revenue.

“Too many patients are being priced out of the medicines they need. While FDA doesn’t have a direct role in drug pricing, we can take steps to help address this problem by facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines,” said Gottlieb.

The development comes in the backdrop of US President Donald Trump and lawmakers’ emphasis on reducing medicine prices in the country. According to a Bloomberg report last week, the Trump administration is preparing an executive order aimed at lowering US drug costs.

Gottlieb said the USFDA is working on a Drug Competition Action Plan and in this regard it intends to hold a public meeting on 18 July to solicit inputs on places where FDA’s rules are being used in ways that may create obstacles to generic drugs access instead of ensuring competition.

Over the last decade alone, generic drugs have saved the US healthcare system about $1.67 trillion, the commissioner said in the blog. The US regulator has observed that innovator companies use certain regulatory norms to delay or block entry of generic drugs in the market and is looking to modify such rules.


“We know that sometimes our regulatory rules might be ‘gamed’ in ways that may delay generic drug approvals beyond the time frame the law intended, in order to reduce competition. We are actively looking at ways our rules are being used and, in some cases, misused,” Gottlieb said.

He said one example of such gaming is the increasing unavailability of certain branded products for comparative testing. To perform the studies required to develop a generic alternative to a branded drug, a generic sponsor generally needs 1,500 to 3,000 doses of the originator drug.

“I understand that generic sponsors are willing to buy these products at fair market value; but, in some cases, branded companies may be using regulatory strategies or commercial techniques to deliberately try to block a generic company from getting access to testing samples,” he said.

Besides limiting access to testing samples, some branded companies may be using the statutory default requirement to have a single shared Risk Evaluation and Mitigation Strategy (REMS) across both the branded and generic versions of a drug as a way to block generic entry, Gottlieb said.

The drug regulator is also looking to coordinate with the Federal Trade Commission (FTC) in identifying and publicising anti-competitive practices.

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