Lawmakers Advance Reforms Of Fast-Track FDA Drug Approvals
The latest legislation is "friendlier" to the pharmaceutical industry than previous drafts, but still cracks down on tricks used to speed new drugs through FDA processes. Separately, the agency warns of poor drug testing standards at a lab run by Miami University.
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Congress Moves Toward Reforming The FDA’s Accelerated Approvals
House lawmakers are moving a little closer toward cracking down on drugmakers that game the FDA’s accelerated approval pathway, but their latest legislation is friendlier to industry than previous drafts. The House Energy and Commerce Committee announced Wednesday that its sweeping user fee authorization bill will include a revised policy from Rep. Frank Pallone (D-N.J.) that would make it easier for the Food and Drug Administration to rescind its approval for drugs cleared through the pathway when drug makers don’t complete required follow-up studies. (Florko, 5/4)
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FDA Warns Miami University Contract Testing Lab Over Falsified Data
A contract testing laboratory run by Miami University was scolded by the Food and Drug Administration for failing to ensure that drugs are appropriately tested and preventing data from being changed or omitted. In an April 20 warning letter, the agency noted the Department of Chemistry and Biochemistry failed to follow good manufacturing practices as it went about testing the raw material used to make heparin, which is relied on to prevent and treat blood clots. The letter, which was posted to the FDA website this week, followed an inspection conducted by the agency last November. (Silverman, 5/4)
The Wall Street Journal:
Telehealth Startup Cerebral To Stop Prescribing Adderall For New Patients
Cerebral Inc. executives told its clinicians that the company will pause prescribing controlled substances such as Adderall to treat attention-deficit hyperactivity disorder in new patients beginning Monday, the company said. Cerebral’s co-founder and chief executive, Kyle Robertson, made the announcement in an email sent to staff on Wednesday, adding that the company will continue to treat existing ADHD patients. (Winkler, 5/4)
The Wall Street Journal:
J&J Sues Drug-Benefit Middleman Over Use Of Drug-Cost Assistance Program
Johnson & Johnson filed a lawsuit Wednesday accusing a drug-benefit middleman firm of improperly exploiting a J&J program that pays out-of-pocket costs for patients who use some of the company’s pricier prescription drugs. J&J, of New Brunswick, N.J., said in the lawsuit that it has paid at least $100 million more in copay assistance than it otherwise would have as a result of the services provided by the firm, SaveOnSP, which has offices in Buffalo, N.Y. (Loftus, 5/4)
