Press Release

PhRMA Statement Regarding Drug Shortages

PhRMA April 26, 2013

Washington, D.C. (May 2, 2011) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Assistant General Counsel Maya J. Bermingham issued the following statement today on the myriad factors that contribute to drug shortages:

“Drug shortages can occur at any point of the supply chain and may be traced to a number of different causes. According to the Food and Drug Administration (FDA) and other experts, drug shortages can occur for any number of reasons ranging from natural disasters; shifts in clinical practices; wholesaler and pharmacy inventory practices; raw material shortages; changes in hospital and pharmacy contractual relationships with suppliers and wholesalers that can cause fluctuations in the availability of certain products; adherence to FDA-mandated distribution protocols, which can impact patients’ timely access to medicines; individual company decisions to discontinue specific medicines; and manufacturing challenges.

“PhRMA’s member companies recognize the importance of avoiding unexpected disruptions in the supply of needed medicines to patients. To achieve that goal, PhRMA companies are committed to maintaining good manufacturing practices and working closely with the FDA, supply chain partners and providers when unexpected shortages occur.

“The lifeline of America’s biopharmaceutical research companies is the safety, integrity and market availability of the medicines that they develop. PhRMA and our member companies share the commitment of the FDA in promoting patient health and safety.

“What’s more, PhRMA organized and leads the RxResponse program, uniting the entire drug supply chain in a coordinated effort to ensure patients’ timely access to medicines during a natural disaster.

“A number of PhRMA member companies also participate in groups, such as Rx360, a consortium of regulators, pharmaceutical executives, supplier executives and members of professional organizations working to develop and to implement enhanced global quality systems and processes to help members ensure product quality and authenticity throughout their supply chains.”

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $49.4 billion in 2010 in discovering and developing new medicines. Industry-wide research and investment reached a record $67.4 billion in 2010.

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