Two agencies, one common goal.
The U.S. FDA and FTC are joining forces to counter unfair practices among drugmakers. The pairing of these agencies could offer a rare window-of-opportunity in shifting the balance-of-power in favour of generic competition.
Branded manufacturers have long been accused of “gaming” regulatory channels - tactics used to delay generic competition. Drugmakers can tweak their products - change packaging - to extend patents. They can also can refuse to sell samples of branded products needed to prove that generic versions are just as effective and safe. And this is where the FTC could intervene.
“I would say this is probably the most coordination we’ve seen between the agencies”
The FTC has the power to investigate and file lawsuits against companies that use “unfair methods of competition”. The agency can monitor and analyze mergers and acquisitions, and what these activities mean for specific classes of drugs as well as the overall market. It can also conduct studies on patent abuse and advise Congress on potential legislation.
While not a cure-all, the collaboration intensifies the focus on conduct within the Pharma industry.
Neither the FTC or the FDA traditionally monitor or regulate drug prices. But they appear eager to step into that space now. The partnership maybe a sign of past Trump promises coming to fruition | @heatinformatics