Social Media, Exclusivity Emerge as Main Controversial Issues in FDA Overhaul
A proposal to lift restrictions on how drugmakers can promote products on social media and another that would grant up to 15 years of generics-free exclusivity to drugs approved to treat an unmet medical need are emerging as controversial issues in a proposal to overhaul FDA drug approval processes.
Reps. Fred Upton (R-Mich.), chair of the House Energy & Commerce Committee that oversees the FDA, and Diana DeGette (D-Colo.) said they are working to introduce a final version of the bill, the 21st Century Cures Act, into the House before Memorial Day.
Over the next several weeks, they will be revising the bill in response to feedback from other legislators and industry to build support for the measure, whose main goal is speeding up drug approvals.
The two spoke at a conference sponsored by BIO in New York City, outlining the issues in the draft bill for Wall Street investors.
Other provisions in the wide-ranging bill would increase orphan drug development, streamline clinical trials oversight, give industry incentives to find new uses for old drugs and expand U.S. drug manufacturing.
In addition, the proposal would offer greater incentives for developing new drugs and antibiotics that treat drug-resistant infections and other unmet needs, including provisions that would allow drugmakers to transfer market exclusivity bonuses from products developed for unmet needs to other, more profitable drugs, delaying generic competition.
It also would require the FDA to review GMP regulations and guidances to eliminate requirements that may hinder manufacturing innovation, expand market protections for drugmakers that reformulate an existing drug to perform better by adding elements such as abuse-deterrent features and allow drugmakers to provide educational medical texts and journal articles to physicians without having to disclose them under the Physician Payments Sunshine Act. — Bryan Koenig