FDA To Encourage Drugmakers To Seek Over-The-Counter Approvals With Aim Of Lowering Prices
“Our ultimate goal with modernizing our regulatory framework for nonprescription drugs is to help facilitate a market that is more competitive, enables greater access to medical products, empowers consumers in their health care decisions, and provides more affordable options for Americans,” FDA Commissioner Scott Gottlieb said.
Stat:
FDA Eyes New Ways To Lower Some Drug Costs, Boost Consumer Access
In its latest bid to address health care costs, the Food and Drug Administration issued a new guidance that offers suggestions for drug makers seeking to switch their prescription medicines to a so-called non-prescription status. The guidance, which the agency called a “first step,” is designed to encourage drug makers to think about ways to seek approval for over-the-counter approvals. A new FDA regulation that would formalize such an approach is expected next year, but the agency emphasized that approval standards for over-the-counter medicines are not being lowered. (Silverman, 7/17)
The Associated Press:
FDA Plans To Ease OTC Approvals For Some Prescription Drugs
Drugmakers would have to do studies showing those strategies allow consumers to safely pick a drug and use it without medical supervision. The agency will take comments from drugmakers, medical groups and the public before issuing final rules, a process that usually takes many months. (Johnson, 7/17)
In other pharmaceutical news —
The Washington Post:
The Truth About ‘Breakthrough’ Drugs
When federal regulators started giving certain drugs “breakthrough” status in 2012, pharmaceutical company interest exploded. The goal was to speed up the approval of drugs for serious diseases when there was preliminary evidence the new drugs were better than existing treatment options. Giving these drugs “breakthrough” status comes with a side benefit: an evocative name. The word “breakthrough” suggests scientific triumphs and miracle cures to many people, including physicians. Companies and media reports often tout the “breakthrough” designation for experimental drugs that have not yet been proved effective. (Johnson, 7/17)
Stat:
Boston-Area Companies Bet On Antibiotics, Even As Others Step Back
Spero Therapeutics (SPRO), headquartered in Cambridge’s Central Square neighborhood, announced this week that two government agencies would give the company up to $54.2 million to continue developing a new antibiotic for complicated urinary tract infections. The news came just days after Novartis revealed it would shut down its antibiotics unit and and license out its drug candidates — including one for a complicated urinary tract infection. (Sheridan, 7/18)
