Associations respond to Bush’s proposed budget in light of industry needs
WASHINGTON Various trade associations have reacted to President Bush’s budget proposal for 2009 with general concern and calls for Congress to re-examine proposed funding for a number of industry-related matters.
The National Association of Chain Drug Stores sent a letter to Department of Health and Human Services secretary Michael Leavitt, objecting to the president’s proposed cuts to Medicaid reimbursements for pharmacies and to the Medicare Part B program. Pharmacies are already facing drastic cuts under the Deficit Reduction Act of 2005, and the president’s budget proposes cutting reimbursements by an additional $1.1 billion over five years. NACDS noted that further reductions could jeopardize patient access to medications.
“For the third-straight year, the president’s budget calls for further cuts to a reimbursement formula that already underpays pharmacies,” stated NACDS president and chief executive officer Steve Anderson. “We are deeply troubled by these proposed cuts. However, we are eager to work with Congress and HHS on provisions that will increase the availability of money-saving generic medications.”
The Generic Pharmaceutical Association called on Congress to increase funding to the Food and Drug Administration’s Office of Generic Drugs. “The return on investment from increased funding and addressing longstanding core issues will pay significant and long-lasting dividends to the federal government as well as for all Americans – individual consumers, employers, and state governments,” stated GPhA president and chief executive officer, Kathleen Jaeger.
“The shared goal of the FDA and the generic pharmaceutical industry should be to bring safe, effective and affordable medicines to consumers in a timely manner,” she said. “But what consumers need is for the FDA to address the core fundamental issues that are blocking timely consumer access to affordable generics. These core issues have been around for more than a decade and include the citizen petition process, scientific consults, enhanced communication, more inspection resources, accountability and structure of the Office of Generic Drug Program.”
NACDS did express its appreciation for a provision to create a regulatory structure that provides a pathway for the approval of generic biopharmaceuticals. GPhA, however, took a more cautious viewpoint: “We welcome the news that the administration has endorsed the fact that FDA has the scientific expertise to establish a safe and workable regulatory approval pathway for biogenerics,” Jaeger stated, but called on the FDA “to provide timely access to biogenerics. A pathway filled with roadblocks to access, including excessive market exclusivity provisions, is an empty promise for countless patients who need these affordable life-saving medicines.”
Another group calling on Congress to increase FDA funding was the Grocery Manufacturers Association, which claimed that the proposed budget increases were simply too low. “The president’s proposal to increase FDA food-related spending by $32 million does little more than cover the cost of inflation and falls short of what is ultimately needed to make certain FDA has the tools it needs to get the job done,” stated GMA president and chief executive officer Cal Dooley. “However, we are confident that Congress will provide the necessary resources to rebuild FDA’s scientific capacity.”
One thing all groups agreed on was the need for cooperation. “In 2008, we should all work together to reach our shared goal of increased access,” GPhA’s Jaeger stated.
And in its letter, NACDS encouraged working together on reducing fraud, waste and abuse in the Medicaid programs “in a manner that will not jeopardize patient access to critical prescription drugs and pharmacy services.”
Lilly and PsychoGenics partner on neuropsychiatric disorder treatments
TARRYTOWN, N.Y. PsychoGenics and Eli Lilly have entered into a drug discovery agreement aimed at identifying drug candidates suitable for clinical developments.
Per the agreement, Lilly will supply precandidate compounds that PsychoGenics will evaluate using its proprietary drug discovery technologies for the treatment of neuropsychiatric disorders. Upon Lilly’s further development of clinical candidates, PsychoGenics would receive research and milestone payments, as well as royalties.
Emer Leahy, president and chief executive officer of PsychoGenics, said, “We are delighted to once again work with Lilly and play an integral and expanding role in a successful drug discovery collaboration. We are confident that by combining the complementary strengths and expertise of PsychoGenics and Lilly, we may identify a new generation of treatments for neuropsychiatric disorders.”
Roche asks for clearance to bring Mircera to market
BASEL, Switzerland Roche is asking a U.S. judge for clearance to sell an anti-anemia drug by offering a royalty to Amgen and offering the drug at a price that is lower than what Amgen charges for its top anemia drug, according to published reports.
Roche won regulatory approval for Mircera as a treatment for anemia associated with kidney disease in November. But it hasn’t brought the drug to market because it lost a civil trial in October in which a federal jury found Mircera violated patents held by Amgen. Amgen sells drugs Aranesp and Epogen to treat anemia associated with kidney disease and cancer chemotherapy.
Although Roche lost the patent trial to Amgen, it is now seeking permission from Judge William Young to bring Mircera to the market by arguing that it would serve the public interest. Roche also has proposed selling Mircera at an initial “wholesale acquisition cost” that is about 5 percent less than the current “average selling price” of Amgen’s Aranesp. Also, it would pay Amgen a royalty 20 percent of net sales of Mircera while Amgen’s patents are still enforced, assuming the original ruling of infringement stands.
Roche said it would begin taking steps to market Mircera if the judge doesn’t rule on Amgen’s injunction request on Feb. 28, when oral arguments are scheduled in the case. Roche would be doing this even though they would be at risk to pay Amgen penalties if the infringement case isn’t overturned.