PPTA Attends FDA Public Workshop on Drug Shortages
ANNAPOLIS, MD - The Plasma Protein Therapeutics Association (PPTA) attended a U.S. Food and Drug Administration (FDA)–sponsored workshop to address growing concerns regarding drug shortages in certain sectors of the pharmaceutical industry September 26.
The workshop convened a diverse group of stakeholders including manufacturers, wholesalers, patients, physicians, regulators and policymakers to address the causes of drug shortages and potential responses. FDA staff expressed an interest in timely, bi-directional communications with stakeholders.
Jan M. Bult, president and chief executive officer, PPTA, made a brief statement during the public comment period indicating that the plasma protein therapeutics industry has a very positive message to deliver and has over a decade of experience administering a North American data program in response to a shortage of intravenous immune globulin (IVIG) products in the late 1990s.
"PPTA member companies are committed to providing safe and efficacious plasma protein therapies to patients who need them," Bult said. "Part of that commitment is ensuring that there is an adequate supply of therapies to meet patients' needs. PPTA's North American Data Program has been a key component of this effort. The program is an example of a highly successful FDA-industry collaboration and we hope it can serve as a model to others."
PPTA's North American Data Program consists of the collection and dissemination of standardized information in a report provided monthly. The aggregated data on the supply of certain plasma protein therapies including Ig, albumin and hemophilia clotting factors is reported directly to manufacturers that contribute data, FDA and the U.S. Department of Health and Human Services (HHS). The information is also reported publicly via PPTA’s website, where it is available to patient advocacy groups, healthcare providers and individual patients. To view the Association's North American Data Program online, please go to: http://www.pptaglobal.org/safety-and-quality/north-america-data-program
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