FDA's Gottlieb reveals plans to tackle generic price abuses

The FDA’s new commissioner, Scott Gottlieb, has outlined plans to tackle companies that hike the price of generics.

Earlier this month Gottlieb revealed first details of an initiative to tackle the tragedy of opioid addiction in the US, and in line with promises by President Trump, he has now moved on to the controversial issue of price gouging.

Gottlieb told a panel of US politicians that he is putting together a plan aimed at improving competition, with faster approvals of generics for branded drugs that don’t have competitors.

The plan is an attempt to crack down on activities of unscrupulous drug firms, such as Turing Pharma under CEO Martin Shkreli, which began the generic pricing controversy with an ultra-aggressive price hike for an old HIV drug.

An important part of Gottlieb’s plan will be to tackle an underhand way that branded pharma uses to stifle generic competition, by withholding safety plans from companies seeking to copy their products.

Under Gottlieb’s plans, generic companies will be able to sue branded firms that withhold their Risk Evaluation and Mitigation Strategy documents.

Another part of Gottlieb’s plan is to improve the approval process for “complex” generics consisting of an old medication with a new delivery system.

Getting such drugs approved is very difficult in the US. While no-one has accused GlaxoSmithKline of any wrongdoing of its pricing, its Advair respiratory drug has been without a generic competitor in the US for years because it is so tricky to get generic-device combinations approved there.

This year, Mylan and Hikma have both seen their Advair generics rejected by the FDA, giving the ageing asthma and COPD drug a further few months on the market without a direct competitor even though its patent expired years ago.

Gottlieb, a respected doctor and former FDA deputy commissioner, also wants to publish a list of off-patent drugs for which there is no generic competitor in order to encourage competition and drive down prices.

Confirmed at the beginning of this month by Congress, Gottlieb’s appointment to the top job at the FDA has been largely backed by industry, although there are concerns about a network of jobs and links with industry that could cause conflicts of interest.