GPhA applauds FDA’s action to address shortage of Doxil, methotrexate
WASHINGTON — The Food and Drug Administration’s action to address the ongoing shortage of certain cancer drugs has garnered praise from a group representing the manufacturers and distributors of generic pharmaceuticals.
The Generic Pharmaceutical Association said it applauded the FDA’s action to address the shortage of cancer drugs Doxil (doxorubicin hydrochloride liposome injection) and preservative-free methotrexate. GPhA also added that generic drug manufacturers are tirelessly working 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,” GPhA president and CEO Ralph Neas said. “GPhA is spearheading the development of the Accelerated Recovery Initiative — 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.”
Rep. Slaughter raises concerns about proposed ESI-Medco merger
WASHINGTON — Rep. Louise Slaughter, D-N.Y., has expressed concerns about the proposed merger between pharmacy benefit managers Express Scripts and Medco in a letter to the Federal Trade Commission.
The letter, dated Feb. 6, outlines how Slaughter represents a district that contains 34 independent pharmacies — which employ 364 full-time individuals — that fill more than two million prescriptions every year.
"The newly merged PBM would control one-third of the total 2011 PBM market share and 60% of the market share for mail-order drugs. This centralization raises the possibility of higher prices for prescription drugs and reduced choices for consumers," the letter stated. "My primary concern is the impact that the merger could have on community pharmacies and patients who rely on them not only for their medicine, but also for counseling and other specialized services and products."
Slaughter’s letter was praised by the Preserve Community Pharmacy Access NOW! coalition, which is seeking to stop the merger.
"The concerns expressed by Rep. Slaughter and so many others are very real – and need to be considered," said former congresswoman Eva Clayton, chairwoman of the PCPAN. "This merger threatens to saddle patients and consumers with higher costs for lesser quality care, it needs to be stopped."
Nearly $1 billion in damages asserted in lawsuit over GERD drug
MUMBAI, India — A division of Pfizer is asserting that it incurred nearly $1 billion in damages related to the launch of generic versions of one of its drugs.
In a lawsuit filed in the U.S. District Court for the District of New Jersey against Sun Pharmaceutical Industries and Teva Pharmaceutical Industries, Wyeth Pharmaceuticals said it estimated that it suffered damages of $960 million from Sun’s and Teva’s launches of generic versions of the gastroesophageal reflux disease drug Protonix (pantoprazole).
In 2010, the District Court had turned down an attempt by Wyeth to reverse a jury’s earlier decision declaring its patent on Protonix invalid. Pfizer acquired Wyeth in 2009.
Several other companies recently have received Food and Drug Administration approval for generic versions of Protonix, including Actavis, Mylan and Dr. Reddy’s.