End slow playing REMS strategies to speed up generic drug development

FDA commissioner Scott Gottlieb has called out brand name drug companies for using tactics that are designed to deliberately restrict generic drug manufacturers from bringing cheaper generic alternatives to market.

Gottlieb, speaking at an FTC sponsored conference, was specifically talking about the tactic of deliberately slow-playing shared Risk Evaluation and Mitigation Strategies (REMS), which enable generic firms to purchase the active drug ingredients required to complete bioequivalence or bioavailability studies in order to gain FDA approval.

To counteract the practice, the FDA has launched new draft guidance proposals which will hopefully make it easier to implement and share a single REMS document.

Under the current system, multiple applicants must synchronize the submission of identical REMS-related documents to compile a single application. The new system involves creating a single Drug Master File (DMF) for shared system REMS submissions. It is hoped this will make it easier for generic manufacturers to obtain the information required and speed up the submissions process by enabling them to submit a single set of files to the agency for approval.

The proposals are the latest attempt by the FDA to prevent brand name manufacturers from keeping drug costs artificially high by restricting the number of generic drugs available on the market. When a generic version of a drug is launched it typically costs 20 to 30 percent less than the equivalent branded version.

During the event, Gottlieb also warned the agency was on the lookout for companies that deliberately slow collaboration on risk strategies. Getting generic drugs to market faster is one of the best ways of combating high drug prices, he said in a statement on Nov. 8th.

But making it easier to file REMS is not the only weapon the FDA is using to combat high drug prices. The agency is also closely monitoring the industry for anticompetitive behaviour and aggressively prosecuting drug companies that are found to have flouted anti-competition laws.

A recent example of this is the prosecution of Impax Laboratories Inc. for allegedly accepting $100 million in bribes to delay the release of its generic opioid pain medication. Brand drug manufacturer Endo Pharmaceuticals, which allegedly paid the sum, has already settled with the FTC.

CONTENT SPONSORED BY

WSGR_HORIZ_CMYK2

In today’s fast-growing, highly regulated generic pharmaceutical market, companies increasingly require specialized legal guidance as their products are developed, launched, and litigated. Wilson Sonsini Goodrich & Rosati’s attorneys address this need by providing expert counsel to companies in the global generics industry, offering sophisticated representation far beyond the scope of general corporate and securities counsel.

We have assembled a highly experienced team of experts from a cross-section of the firm’s key practice areas, including intellectual property, litigation, antitrust, FDA/regulatory, technology transactions, exports and FCPA, trade secret, and trademark and copyrights. Led by the former chief legal officer of Mylan Pharmaceuticals, one of the world’s leading generic and specialty pharmaceutical companies, our attorneys work closely with our generic pharmaceutical clients’ legal and scientific personnel and senior management to understand and meet their specific needs both in the U.S. and abroad.