PhRMA CEO John Castellani Responds to New York Times

PhRMA CEO John Castellani Responds to New York Times

10.24.12 | By Kaelan Hollon

Our President and CEO John Castellani was published in the New York Times' Letters to the Editor this morning, in response to a recent story about compounding pharmacies and drug shortages. Recognizing that space is tight on the Times' opinion pages, we've included the full text of his submitted letter here.

In "Lapses at Big Drug Factories Add to Shortages and Danger "(17 October 2012) Katie Thomas suggests an overlap between recent issues surrounding compounding pharmacy practices and biopharmaceutical manufacturers' drug shortages, which is misleading to patients. The recent meningitis outbreak demands resolution for the families affected by this tragedy, and further, a focus on the safe development and delivery of medicines.

Patient safety is a top priority for America's biopharmaceutical research companies, who work closely with the FDA to ensure the integrity of the products they manufacture. According to the FDA, about 97% of the drugs approved over the past two decades are still on the market and considered safe. The compounding pharmacy identified in the meningitis outbreak, however, is not an FDA-regulated manufacturer. While the scope of the company's distribution of compounded products would seem to require consistent regulation to ensure the best possible care and safety for patients, it is not currently regulated by the FDA in the same way as biopharmaceutical companies.

As the article noted, over the last several years, the number of sterile injectable products in shortage increased. Those shortages occur for a variety of complex reasons, many unrelated to the manufacturer. While the vast majority of recent shortages involved generic, sterile injectable drugs, innovative manufacturers remain firmly committed to maintaining good manufacturing practices, and collaborate closely with the FDA, supply chain partners and healthcare providers and their patients when unexpected - and rare - shortages of brand-name medicines occur.

The good news is that thanks to increased efforts to address drug shortages since last year, the number of shortages decreased nearly fifty percent, according to the FDA. Further, there has been a six-fold increase in early notification of potential supply interruptions, allowing the FDA more time to resolve a potential shortage.

While the issue of drug shortages continues to exist, progress is being made. It is important, however, not to confuse the current compounding problem with drug shortages generally.

John J. Castellani
CEO
Pharmaceutical Research & Manufacturers of America

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