New Food and Drug Administration draft guidance on pharmaceutical compounding drew criticism this week from the American Academy of Dermatologists, whose president said the policies could erode patients’ access to important therapies.
“Many of the more than 3,000 skin diseases that dermatologists care for use compounded pharmaceutical treatments,” AAD President Brett Coldiron said in a statement. “Many of these diseases are rare and do not have cures or FDA-approved treatments. But we’ve seen patients’ quality of life markedly improve as a result of personalized care with compounded medications.”
Published Feb. 13, the five draft FDA documents specify that “biological products” that are “mixed, diluted, or repackaged” by physicians, pharmacies, federal facilities, or outsourcing facilities must meet specific licensing requirements.
Dr. Brett Coldiron
The policies “are critical to protecting the public health,” according to the FDA. But dermatologists are “most concerned about FDA’s guidance that does not allow for in-office compounding,” Dr. Coldiron said in an interview. “For example, take a patient with a rare and debilitating skin disease. Dermatologists can provide immediate relief by dispensing safe and effective compounded treatments in their office. Patients shouldn’t have to wait 1 or 2 days to get access to their medication.”
While the draft policies note that physicians would not necessarily have to license individualized mixtures of FDA-approved allergenic extracts used for subcutaneous immunotherapy, they do not similarly exclude topical compounded agents used for orphan skin diseases and other dermatologic conditions.
“Why would we take that away, particularly in an era of personalized medicine?” Dr. Coldiron said. “Dermatologists must maintain full access to in-office compounding to ensure quality patient care.”
The new proposals come in the wake of the Drug Quality and Security Act, which Congress passed in November 2013 to improve regulators’ ability to trace drugs through the pharmaceutical supply chain and to track and report adverse events related to the use of compounded medications.
Enactment of the law followed an outbreak of 751 cases of fungal meningitis among patients who received contaminated, preservative-free medroxyprogesterone acetate (MPA) steroid injections prepared by the New England Compounding Center in Framingham, Mass. A total of 64 patients died in the outbreak, and federal prosecutors later charged two NECC executives with 25 related counts of second-degree homicide. (Twelve other NECC-affiliated individuals were charged with racketeering, mail fraud, conspiracy, contempt, structuring, and violations of the Food, Drug and Cosmetic Act.
But nonsterile topical compounded medications pose substantially less risk to patients than do compounded injectables and related solutions that are meant to be sterile, Dr. Coldiron said. For example, a published review of outbreaks linked to compounding pharmacies between 2000 and 2012 implicated flush and cardioplegia solutions, as well as ophthalmic and injectable medications, but not topical agents (Am. J. Health. Syst. Pharm. 2013 Aug. 1 [doi:10.2146/ajhp130049]). Based on such data, the AAD has supported differential, risk-based regulation of pharmaceutical compounding and has maintained that any new policies on compounding should grant physicians “full access to topical compounded products, including in-office use, without overly burdensome regulatory restrictions” that could limit treatment access. The AAD also has opposed limiting access to commonly used, nonsterile topical products from traditional compounding pharmacies.
The draft FDA policies are open for public comment at www.regulations.gov for 90 days after the guidance is published in the Federal Register. The first meeting of the FDA’s reconstituted Pharmacy Compounding Advisory Committee will be held Feb. 23-24.