Abbott Warned on Depakote
The Food and Drug Administration warned Abbott Laboratories that a promotional campaign for its products Depakote and Depakote ER was false and misleading and that it omitted important safety information. The campaign consisted of a flashcard sent to health care providers. The FDA said the card was misleading because it left out the risks, which include a boxed warning about hepatotoxicity, in the main body. It also implied the ER formulation was indicated for use in a broader group of patients than the conventional formulation, but that is not the case. The agency asked Abbott to immediately cease distribution of the card. The drugs are prescribed for seizure disorders, migraine, and bipolar disorder.
CNS Drugs Rank High in Cost
Medications that affect a person's central nervous system accounted for about $28 billion of the $208 billion American adults spent on prescription drugs in 2006, said the Agency for Healthcare Research and Quality. Metabolic drugs topped the list at $38 billion, cardiovascular drugs cost $33 billion, psychotherapeutic drugs cost more than $17 billion, and hormones cost $14 billion. The agency also found spending for outpatient prescription analgesics rose from about $4 billion in 1996 to more than $13 billion in 2006.
Boston Limits Tobacco Sales
Boston has banned tobacco-product sales at pharmacies and on college campuses. The Boston Public Health Commission's board of health also banned new permits for smoking bars, such as hookah and cigar bars, and prohibited the sale of blunt wraps, a tobacco leaf often used to roll marijuana. The board said it was working to increase people's access to smoking cessation resources. Last year, San Francisco imposed the first municipal ban on cigarette sales by pharmacies. Many college campuses already ban tobacco.
FDA Device Enforcement Lax
A nonprofit watchdog group says the Food and Drug Administration is not adequately monitoring manufacturers' testing of medical devices. The Project on Government Oversight (POGO) reviewed FDA enforcement of its quality assurance standards for devices such as implantable cardiac defibrillators, pacemakers, and stents. The group said agency inspections have dropped from 33 labs in 2005 to 1 in 2008, and that a laissez-faire culture exists at the FDA's Center for Devices and Radiological Health. It said internal FDA documents show that many CDRH scientists have challenged management on its lack of enforcement, but they have been rebuffed. POGO called on Congress to investigate what it alleges is a deliberate decision by CDRH senior management not to enforce FDA rules.
Court Shields Billing Records
An appeals court has ruled against the release of Medicare billing records, which was sought by the group Consumers' Checkbook so that it could grade physicians on quality. The nonprofit gorup had filed a Freedom of Information Act request for all 2004 Medicare claims from physicians in several locations, and the group won in a lower court in 2007. But the Department of Health and Human Services, joined by the American Medical Association, appealed, and the United States Circuit Court of Appeals for the District of Columbia ruled that HHS does not have to release the information. Disclosure of the requested data would constitute an invasion of physicians' privacy, the court said. The American Medical Association praised the decision. “The court clearly found that the release of personal physician payment data does not meet the standard of the Freedom of Information Act, which is to provide the public with information on how the government operates,” Dr. Jeremy A. Lazarus, AMA board member, said in a statement.