SWEDESBORO, N.J.--(BUSINESS WIRE)--Wedgewood Pharmacy will continue to prepare and dispense 1ml, 5ml and 10ml multi-dose vials of 17P (Hydroxyprogesterone Caproate). The drug often is prescribed to prevent premature births.
The announcement followed a news release from the Food and Drug Administration (FDA) that it “does not intend to take enforcement action against pharmacies that compound” the substance.
On February 3, KV Pharmaceutical Company (NYSE: KV-A, KV-B, and KVPHP) received approval to sell a manufactured version of the drug, Makena®. But the $1,500-per-dose price of the drug, a 150% to 200% increase over the current cost to physicians and patients, has raised a storm of controversy and protest. A typical course of treatment would go up in cost from a few hundred dollars to more than $30,000 per patient.
Under normal circumstances, compounding pharmacies must stop making a prescription drug when the same drug is manufactured as a commercial product. The FDA’s announcement said that the agency would allow compounding pharmacies to continue providing the drug “at this time and under this unique situation.”
George J. Malmberg, R.Ph., F.A.C.A., F.A.C.V.P., Wedgewood Pharmacy’s president and CEO, said, “We applaud the FDA’s decision. As compounding pharmacy specialists, we have provided physicians and their patients with the compounded version of 17P for many years. Like all concerned, we are committed to making sure that patients at risk have access to this life-saving medication.”
The reactions of legislators, regulators, healthcare organizations, medical associations, financial analysts and consumer groups to Makena’s price have been strong. A variety of formal and informal actions against the manufacturer have been taken and are being proposed, including Congressional demands for action by the Federal Trade Commission and the Food and Drug Administration. Wedgewood Pharmacy has created a page on its human-health website, WedgewoodRx.com, to provide links to communications from government officials and medical societies to the manufacturer, the FDA and the FTC, as well as news and opinion from respected sources.
For patients with certain sensitivities, for whom the use of Wedgewood Pharmacy’s regular formulation of 17P is contraindicated, the company also will provide a preservative-free 17-alpha hydroxyprogesterone caproate, 250mg/ml, in single-dose vials.
Malmberg adds, “This formulation of 17P undergoes the same rigorous compounding and quality control processes as the company’s current formula.” These include preparation under laminar airflow hoods in its suite of clean rooms, and quarantining each batch pending return of independent laboratory test results for potency, sterility and pyrogens. The preservative-free version of 17P will be available for prescribing by April 15, 2011.
Established in 1980, Wedgewood Pharmacy is one of the largest compounding pharmacies in the United States, providing more than 25,000 prescribers with compounds for their human and veterinary patients. It is located in Swedesboro NJ and licensed throughout the United States.