December 2007 Drug News
FDA hears arguments for “behind-the-counter” drug dispensing
FDA officials will listen to arguments today to determine if pharmacists should be allowed to provide prescription drugs directly to patients. These medications would be part of their own class, “behind-the-counter,” and would only include certain medications such as cholesterol drugs and birth control pills. While supporters say the move could advance patient care and improve medication use, critics say that the FDA needs legislation to establish legal authority and that patients need physician diagnosis and management. HealthDay News (11/13)
Medicare late to collect $4.4 billion in drug overpayments
Medicare should more promptly collect refunds for its overpayments to the health insurers participating in its prescription program, a government reports says. Overpayments to health care companies, including Humana and UnitedHealth Group, totaled $4.4 billion in 2006 and amount to “zero-interest loans from Medicare,” one congressman said. Bloomberg (11/7)
AHIC urges e-prescribing legislation
Following a unanimous vote on Tuesday, the American Health Information Community will recommend the HHS pursue legislation requiring e-prescribing. The proposed legislation would require doctors seeking payment from Medicare to use electronic prescribing with patients. Modern Healthcare (free registration) (11/13)
Zyrtec gets OK for use without a prescription
The FDA has approved Johnson & Johnson’s Zyrtec for over-the-counter sales. Johnson & Johnson acquired Zyrtec, which treats allergy symptoms, from Pfizer in 2006, along with the entire Pfizer Consumer Healthcare business. Forbes/Associated Press (11/9)
Cobalt seeks approval for version of AstraZeneca’s Crestor
Canadian firm Cobalt Pharmaceuticals has applied for FDA approval to market its generic version of AstraZeneca’s cholesterol treatment Crestor, giving the British drug giant 45 days to file a patent infringement suit against the generic drug maker. Two AstraZeneca patents for Crestor expire in 2016 and 2020, and the company said it is confident that its intellectual property portfolio will protect its rights to the drug. Bloomberg (11/1) , The Washington Post/Reuters (11/1)
AstraZeneca’s Crestor gets expanded FDA approval
The FDA is allowing wider use of AstraZeneca’s cholesterol-lowering drug Crestor for the treatment of atherosclerosis. The regulatory nod makes Crestor the first cholesterol medicine to win approval to treat arteries clogged by fat deposits, and is expected to bolster sales for the drug giant. Bloomberg (11/8) , Reuters (11/9)
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