Latebreakers: January 22, 2007

House Democrats to push for Medicare drug negotiation

Pharmacy industry leaders are anxiously awaiting details on the Democrats' plan to allow CMS to negotiate directly with drug manufacturers. Currently, CMS is prohibited from taking such action. A study released by Families USA, an advocacy group that has been critical of the Medicare Part D program, suggested that CMS may be paying 58% more for some prescription drugs than the Department of Veterans Affairs, which is permitted to negotiate directly with drug manufacturers. The House was scheduled to debate the measure on Jan. 12, but, if passed, it would still need to pass the Senate and is likely to face a veto from President Bush. While most industry organizations are withholding comment before the measure is introduced, AMCP has announced it would "oppose changes that ... dilute the competitive structure" of Medicare Part D. The final measure was not available at press time.

Watch out for new juggernaut: Health Mart

Antibiotic gets new indication

Restrictions eased on addiction therapy

President Bush recently signed a new amendment to the Controlled Substances Act (CSA) raising the number of patients a physician may treat with buprenorphine from 30 to 100. The new law will affect prescribing of both Suboxone (buprenorphine/naloxone) and Subutex (buprenorphine) sublingual tablets, both made by Reckitt Benckiser and used to fight heroin addiction. Advocates of the increased "cap" say the previous limit of 30 patients per physician resulted in many opioid-dependent patients going untreated. To qualify for the higher prescribing limit, doctors must have been certified to treat opioid dependence with buprenorphine for at least a year. The new law is the second amendment to CSA. The first amendment came in July when Congress lifted a provision of the Drug Addiction Treatment Act of 2000 that set the prescribing limit at 30 patients per group medical practice or large institution, even if multiple physicians within the practice or institution were certified to treat with the drug, a restriction that seriously limited patient access to buprenorphine.

FDA wants to allow new supplement claims

The FDA is proposing to allow new claims on foods and dietary supplements containing calcium and vitamin D to show their potential to reduce the risk of osteoporosis. The proposed rule, published in the Jan. 5 Federal Register, would allow manufacturers to include new information on their labeling and to eliminate certain other information. Comments may be submitted by March 21 to http://www.regulations.gov/ or http://www.fda.gov/dockets/ecomments/. (For more on calcium, see story.)