Regulatory/Legislative News

by Jonathan P. Jarow, MD

Barbara L. McAneny, MD, will be the first oncologist to lead the AMA when she assumes the association’s presidency next year.

The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted favorably on questions of efficacy regarding Aerie Pharmaceuticals’ glaucoma drug Rhopressa.

An FDA advisory committee voted unanimously that Spark Therapeutics’ Luxturna gene therapy for retinal dystrophy has an overall favorable benefit-risk profile.

In the cover story of this issue of OSN, we tackle the conundrum of compounding pharmacies. To put it simply, the problem is that patient safety always comes first, but access to unapproved drugs is sometimes vital to saving lives, or at least eyes.

In 2012, New England Compounding Center released a batch of methylprednisolone tainted with fungus that resulted in an outbreak of fungal meningitis. After it was confirmed that the outbreak was caused by the compounded drug, the FDA imposed new regulations on compounding pharmacies and how they produce drugs. According to some ophthalmologists and representatives in the pharmaceutical business, these regulations have made the procurement and production of several compounded drugs difficult. And that difficulty can affect practice.

The FDA is warning against the use of prophylactic intraocular vancomycin formulations during cataract surgery because there is a risk for hemorrhagic occlusive retinal vasculitis.

Allergan’s announcement that it would partner with a Native American tribe to protect the intellectual rights to Restasis was the most-read story on Healio.com/OSN in September. Other top stories included business updates and clinical trial results.

Tom Price, MD, today offered his resignation as HHS secretary, according to a statement from the White House.

The FDA has accepted an investigational new drug application for OCU310, a topical formulation for the treatment of dry eye disease, according to a press release from Ocugen.