PHARMACY

Allow e-prescribing of controlled drugs, key senators urge Obama administration

BY Jim Frederick

WASHINGTON The drive to convert the nation’s physicians and pharmacies to electronic prescriptions got a major boost Thursday, courtesy of the U.S. Senate.

An influential, bipartisan group of 11 senators appealed to the Obama administration to accelerate and broaden the adoption of paperless prescribing by striking down longstanding barriers to the new, streamlined technology. The lawmakers asked Attorney General Eric Holder and Kathleen Sebelius, newly confirmed secretary of Health and Human Services, to quickly put federal regulations in place that would allow electronic prescribing for controlled substances.

A spokesperson for the National Association of Chain Drug Stores called the bipartisan action “a very positive development.”

The list of those making the request reads like a who’s-who of some of pharmacy’s biggest supporters in Congress. It includes Senators Sheldon Whitehouse (D-R.I.), Tim Johnson (D-S.D.), Tom Coburn (R-Ok.), Jay Rockefeller (D-W. Va.), Edward Kennedy (D-Mass.), Debbie Stabenow (D-Mich.), Sherrod Brown (D-Ohio), Lindsey Graham (R-S.C.), John Kerry (D-Mass.), John Thune (R-S.D.), and Richard Burr (R-N.C.). Together, they urged HHS and the Justice Department to move quickly to overturn Drug Enforcement Administration rules banning e-prescribing of pain medications, antidepressants and other controlled medicines.

“This issue is particularly important with broader health care reform looming on the horizon,” the senators wrote. “While e-prescribing is by no means the key to reform, it is an important piece of the puzzle.”

The lawmakers cited studies showing that widespread e-prescribing, used today in about 18% of doctors’ practices, could save $20 billion a year. Among the factors behind those projected savings, they noted, are that “patients would experience fewer adverse drug events and would be more likely to adhere to a medication regimen.”

Despite those advantages, “current federal rules require that doctors write paper prescriptions for controlled pharmaceuticals,” the senators told Sebelius and Holder. “As a result, most doctors resort to writing all their prescriptions by hand rather than maintain a paper system for controlled substances and an electronic system for non-controlled substances.”

After “four years of inaction,” the senators charged in their letter, the DEA issued a new draft rule last June that would lift the prohibition against e-prescribing for controlled substances. However, they added, the rule has not yet been finalized.

“As DEA moves towards a final rule, it is vital to remember that e-prescribing of controlled substances is an issue involving serious health care and law enforcement concerns,” the group of senators wrote Thursday. “Crafting a final rule that advances both healthcare quality and efficiency, and reduces illegal prescription drug diversion, will require the cooperation, compromise, and knowledge of experts at both the Department of Justice and the Department of Health and Human Services.

“In the past, this process has been decelerated and derailed by disagreements between your Departments.  We are now in a new year, a new Congress, and a new Administration, it is our sincere hope that this process will move forward in a collaborative and expeditious manner.”

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Pfizer signs licensing agreement with Wisconsin Alumni Research Foundation

BY Alaric DeArment

MADISON, Wis. The world’s largest drug maker has signed a licensing agreement with a patenting and licensing organization for the Univeristy of Wisconsin-Madison to use human embryonic stem cell patents to develop new drug therapies.

Pfizer said that under its agreement with the Wisconsin Alumni Research Foundation, the license will the company the rights to work with hES cells for drug research and discovery.

“Our license with WARF provides us with information and materials that will allow us to use their cell lines to explore a whole range of therapies,” Pfizer Regenerative Medicine chief scientific officer Ruth McKernan said. “Stem cells can be used to create specialized human tissue. Our scientists will determine how new medicines may be able to improve the way stem cells regenerate damaged tissues.”

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GlaxoSmithKline to sell U.S. Wellbutrin XL rights to Biovail Corp.

BY Alaric DeArment

RESEARCH TRIANGLE PARK, N.C. A drug maker announced Wednesday that it would give up U.S. rights to the extended-release formulation of a popular antidepressant.

GlaxoSmithKline said it would divest full commercial rights to Wellbutrin XL (bupropion hydrochloride) in the United States, selling it to Biovail Corp. for $510 million. Generic competition to Wellbutrin XL began at the end of 2006 for the 300-mg tablets and during the second quarter of 2008 for the 150-mg tablets. The drug had sales of $60 million in first quarter 2009.

“We are actively reshaping our U.S. business and managing the transition occurring in our product portfolio,” GSK president North American pharmaceuticals Deirdre Connelly said. “This transaction is one of a series of actions we are taking to maximize the value of our current assets and to enable us to resource and invest in new products and upcoming launches.”

Under the terms of the agreement, GSK will transfer the regulatory approval application and trademark for Wellbutrin XL to Biovail for use in the United States, though it will retain rights to the drug for other countries.

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