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FDA commits to speed up approvals of inexpensive generic medicines

The U.S. FDA is reportedly planning to accelerate the approval of cost-effective generic drugs in a move to reduce monopoly in the pharmaceutical industry and lower prescription drug prices.  According to Scott Gottlieb, the commissioner of FDA, the federal agency of the country is supporting the Trump Administration’s endeavor to reduce drug costs for consumers.

Gottlieb is of the opinion that if firms have introduced breakthrough products on which they have invested substantial capital, they should be officially permitted to decide the product’s market value. He further added that this might obviously lead to the company gaining monopoly in the drug market, however, it should not last for a prolonged period, which is what the FDA is attempting to facilitate, he opines.

Some of the cancer drug officials are of the view that there would be no barrier to drug approval, as long as there’s good data. Neither does cutthroat competition reduce drug costs, they state, emphasizing that the contribution by healthcare insurers as well as the support of pharmacy benefit managers plays a key role in drug pricing. The prices of novel cancer immunotherapies remain high despite intense competition, they claim, laying out supporting evidence to their statement.

Sean Bohen, the chief medical officer of AstraZeneca, has however stated that though the competition may not impact the costs of cancer drugs, it can impact the prices of other drug classes. He even appreciated the FDA’s efforts in bringing new drug therapies in the industry.

Incidentally, Gottlieb believes that since the last one and a half decades or so, the time required to market a second drug in a new class has increased substantially. However, it has been reported that the FDA has been undertaking plans to speed up the introduction of new drugs through quicker approvals.

Dhananjay Punekar: