E-prescribing Controlled Substances
Starting June 1, physicians will have the option of electronically prescribing controlled substances. The U.S. Drug Enforcement Administration said it wants clinicians to take advantage of new technology while maintaining the current control system. The agency also said that e-prescribing could reduce paperwork and forgery. The interim final rule outlines the security precautions, such ashphysician identity confirmationed by an authorized third party.
Topamax Case Settled for $81 Million
Two drug companies owned by Johnson & Johnson will pay more than $81 million to settle criminal and civil charges that they illegally promoted the epilepsy drug Topamax for off-label psychiatric uses. Under the agreement reached with the Department of Justice, Ortho-McNeil Pharmaceutical LLC will plead guilty to a misdemeanor and pay a $6 million criminal fine for promoting Topamax for psychiatric uses through its “Doctor-for-a-Day” program. Another Johnson & Johnson subsidiary, Ortho-McNeil-Janssen Pharmaceuticals, will pay more than $75 million to settle the charge that it caused false claims to be submitted to government health care programs for uses of the drug that were not medically accepted indications. Ortho-McNeil-Janssen denies that it engaged in any wrongful conduct. Health and Human Services Inspector General Daniel R. Levinson said in a statement that the agreement requires Ortho-McNeil-Janssen to avoid future illegal drug promotion.
Gulf War Illnesses Need Attention
The U.S. government has committed more than $400 million for research on Gulf War illnesses, but veterans with symptoms need more, according to a draft report from the Gulf War Veterans' Illnesses Task Force. The task force suggested that the VA do a better job of training primary care physicians, environmental health clinicians, pension examiners, mental health professionals, and social workers about Gulf War illnesses. It also recommended the VA work with the Centers for Disease Control and Prevention to include veteran-specific data collection in its national surveys.
Groups Push FDA Drug Enforcement
Two minority advocacy groups are urging the Food and Drug Administration to work harder to remove unapproved drugs from the market. The National Minority Quality Forum (NMQF) and MANA, a national Latina organization, both asked the FDA to push harder on its effort to remove unapproved drugs from the market, which was launched in 2006. MANA said that only 400 of what could be thousands of unapproved drugs have been removed from the market since 2006, and NMQF warned that patients and physicians may not know some drugs are unapproved. “These unapproved drugs, which have not been evaluated by FDA's rigorous approval process, may compromise the health of patients and create increased liability for the physicians who prescribe them,” the NMQF said in its letter.
Chemical Reforms Introduced
After several months of hearings, Sen. Frank Lautenberg (D-N.J.), who chairs a Senate environmental health subcommittee, has introduced a bill that would significantly strengthen federal enforcement powers over potentially toxic chemicals. The “Safe Chemicals Act of 2010” would grant the Environmental Protection Agency new powers to ask chemical manufacturers for safety information, to categorize chemicals by risks they pose, and to remove dangerous chemicals from the market. “The EPA has been able to require comprehensive testing on just 200 of the more than 80,000 chemicals produced and used in the U.S.,” according to advocacy group Health Care Without Harm, which supports strong reforms.