Regulatory/Legislative News

RegeneRx Biopharmaceuticals has received orphan drug designation from the U.S. Food and Drug Administration’s Office of Orphan Products Development for thymosin beta 4 to treat neurotrophic keratopathy, according to a press release.

Kala Pharmaceuticals has submitted an investigational new drug application to the U.S. Food and Drug Administration for a mucus-penetrating particle formulated loteprednol etabonate ophthalmic nano-suspension drug to treat inflammation and pain after cataract surgery, according to a press release.

The U.S. Food and Drug Administration has approved the OphtaCath lacrimal duct balloon catheter from FCI Ophthalmics, according to a press release.

A report issued by the HHS Office of the Inspector General in December 2013 should put successful physicians with large Medicare practices on notice: the government is watching. For many years it has been presumed that high-volume practitioners are more likely than others to be subject to government scrutiny. Fairly or unfairly, the Medicare program is inherently suspicious of practices that generate a high volume of Medicare payment. Further, if problems are identified with a high-volume practitioner, and an overpayment is identified, the recovery will likely be greater.

The American Medical Association praised what it called “strong bipartisan votes” by two Congressional committees to replace the current Medicare sustainable growth rate formula and end the “annual cycle of draconian Medicare physician payment cuts and short-term patches” on physician reimbursement.

Italy: Mandatory prescriptions and differences in co-payment

Non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas are being voluntarily recalled, according to a press release from the U.S. Food and Drug Administration. Injectable medications, intravenous injections, eye drops, pellet implants, nasal sprays, inhalation solutions and eye ointments are included in the recall and were distributed between June 17, 2013, and Dec. 17, 2013, according to the release.

Alimera Sciences and the U.S. Food and Drug Administration have begun discussing labeling for the Iluvien implant, and as a result, the company is not required to participate in the Dermatologic and Ophthalmic Drugs Advisory Committee meeting scheduled for Jan. 27. According to a press release from Alimera, the company will draft a response to a complete response letter it received from the FDA in October and submit it in the first quarter of 2014. Alimera intends to address concerns the FDA raised regarding the facility where Iluvien (sustained-release fluocinolone acetonide) is manufactured and draft a safety update on Iluvien with data from the United Kingdom and Germany, where the implant is approved and commercially available, the release said.

The U.S. Food and Drug Administration and the European Medicines Agency have launched a joint initiative to share information on inspections of bioequivalence studies submitted for generic drug approvals, according to a press release. The collaboration will provide a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies, the release said. Key objectives of the initiative are to streamline information regarding inspections of bioequivalence studies for generic drug applications; share information about negative inspection outcomes; conduct joint inspections at worldwide facilities; and provide training opportunities to improve bioequivalence inspections.

The Senate Committee on Finance and the House Committee on Ways and Means bills that were scheduled for a vote last week were initially identical. The American Academy of Ophthalmology felt that they were not fair to specialists, including ophthalmologists. So, we asked for a number of changes. In fact, we joined the American College of Surgeons in a letter outright opposing the draft bills as written.