PRESS RELEASE

The Generic Pharmaceutical Association (GPhA) today commended the U.S. Food and Drug Administration (FDA) for its action to address the ongoing shortage of the cancer drugs Doxil (doxorubicin hydrochloride liposome injection) and preservative-free methotrexate. GPhA also praised the rapid response of the generic manufacturers who are working tirelessly with regulators to provide needed supplies of the critical medicines.

“As FDA Commissioner Margaret Hamburg said this morning, patients and families waiting for these drugs will soon be able to get the medication they need thanks to the collaborative work of FDA, industry, and other stakeholders,” said GPhA President and CEO Ralph G. Neas.

The generic industry believes believes additional steps could be taken to provide early warning of future shortages and alleviate the need for emergency measures such as those taken by the FDA to address the Doxil and methotrexate shortages. “GPhA is spearheading the development of the Accelerated Recovery Initiative (ARI) — an unprecedented multi-stakeholder undertaking that would work with entities across the supply chain to enhance communication and strengthen our collective ability to prepare for potential shortages and make sure patients do not face situations where their medicines are not available,” Neas said.

The focus of the ARI is to apply proactive industry-driven practices to provide accurate, timely and comprehensive information about drug shortages. Information made available through the ARI and its Independent Third Party (ITP) would enable real time decisions related to manufacturing capabilities and production of priority products. This voluntary initiative will take place in conjunction with the excellent work currently being done by the FDA to expedite regulatory reviews and work closely with manufacturers. Also, GPhA is working closely with Congressional committees and the FDA to ensure that all initiatives are mutually reinforcing and complementary.