FDA Chief Proposes Rules Changes to Fight High Drug Prices

[question everything]

The new commissioner of the Food and Drug Administration plans a multifaceted effort to restrain high prescription-drug prices, centered on speeding cheaper generic medicines onto the U.S. market.

Previous FDA commissioners have largely professed inability to act on drug costs, even as prices of drugs for cancer, hepatitis and other illnesses climbed to as much as hundreds of thousands of dollars per year or even therapeutic course. The FDA’s job, they said, is to assess safety and efficacy, and little else.

But two weeks into his tenure running the federal safety agency, Scott Gottlieb is setting an activist agenda he dubbed the Drug Competition Action Plan, on the generic-drug issue, which has until now mostly been the province of Democrats in Congress.

(snip)

Dr. Gottlieb plans, for example, to have the agency intervene in cases in which brand-name drug companies are accused of using FDA safety rules to refuse to make drugs available to generic manufacturers. Generic companies need those products to manufacture equivalent ones... Sens. Patrick Leahy (D., Vt.), Chuck Grassley (R., Iowa), Amy Klobuchar (D., Minn.) and Mike Lee (R., Utah) are sponsoring a bill that would enable generic makers to sue a brand company to obtain access to a drug.

(snip)

Part of the commissioner’s drug-price initiative will be simply an effort to accelerate generic-drug approvals by reducing the backlog of applications at the agency. The backlog will never be eliminated completely, but as of now, the workload is 2,640 applications, of which 1,484 have been sent back to companies for changes.

Dr. Gottlieb also is calling on the FDA to ease generic versions of “complex” drugs onto the market. These are drugs that are no longer patent-protected but lack generic competition for various reasons. For one, if the medicines are applied to the skin or eyes or in inhalers or injectors, it can be especially difficult under current FDA rules for generic drug manufacturers to prove equivalence. Such drugs include multibillion-dollar products like Mylan NV’s EpiPen auto-injector for anaphylactic shock, GlaxoSmithKline PLC’s Advair for asthma, and diabetes drug Lantus from Sanofi SA .

Dr. Gottlieb is also calling on the FDA to regularly make public lists of older medicines that still don’t have generic competition, in an effort to lure generic companies into the market.

More..

https://www.wsj.com/articles/fda-chief-proposes-rules-changes-to-fight-high-drug-prices-1495722114

[Me.]

1. Boy I Hope He Succeeds

Had to get eye drops which turned out to cost $141. and when I questioned the price, he told me that without my insurance they would cost a grand. Insane!