The new FDA commissioner Dr. Scott Gottlieb, who was confirmed in May, has made his main goal clear: streamlining FDA operations to get new generic drugs and medical devices available more quickly. An analysis by the FDA suggests that the introduction of two generic versions of a drug cuts the price by almost half of the original. Gottlieb said in late June that the FDA will now give priority reviews to new generic drugs until there are at least three on the market. That's the point at which prices drop dramatically up to 80-85% less than the branded version. To increase competition and drive down prices, about a month ago the agency published its first list of brand-name drugs that no longer have a patent's protection but don't yet have generic equivalents.

 

Faster Drug Reviews and Approvals
Once generics are developed, it can take years to get them approved. Gottlieb believes he can reduce the time between development of a drug and it’s availability in a pharmacy down to 8 to 10 months without compromising safety. Though budget may play a factor in his success in this task, Gottlieb says the agency is looking at ways to eliminate the backlog of 2640 generic drug applications within a year. Gottlieb also planned to eliminate the backlog of 200 orphan drug designation requests within 90 days and vowed to strive to address all future orphan designation requests within 90 days. Orphan drugs treat diseases so rare that they have limited opportunities for profitability because of the small market (less than 200,000 Americans affected by the disease). To encourage development for those affected by rare diseases, the FDA designation of “orphan drug” provides financial and other incentives to pharma companies such as seven years of exclusive marketing rights granted by the FDA, tax credits, FDA fee exemption, and R&D grants. As long as it is done safely, eliminating backlogs and reducing FDA review time has the potential to benefit both patients and life science companies.

 

Digital Health Medical Devices and Software
There’s good news for medical device and software companies. Gottlieb said he's creating a "digital health innovation plan" that will clearly outline how devices will be regulated so that manufacturers easily understand the rules and don't have to seek out the FDA's position on a "case-by-case basis." Gottlieb also said the FDA is looking at supporting developers of lower risk digital health products to "reduce the time and cost of market entry." The new commissioner expressed interest in certifying medical software company’s processes rather than each individual product which would allow for a less cumbersome review process for software companies updating their products. Gottlieb also wrote in a blog in June that post-market collection of real-world data on device safety and efficacy could also be used to expand indications of existing medical device products.

 

Who Will Benefit the Most?
Generic drug manufacturers and health IT start-ups seem well positioned to benefit the most from Gottlieb’s plans. However, patients and the entire pharma and medical device industry stands to gain from improved FDA efficiency if Gottlieb is able to achieve his goals.

 

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