FDA Proposes New Ad Rules
The Food and Drug Administration wants manufacturers to detail more of the contraindications and potential side effects of drugs in radio and television direct-to-consumer advertisements. The proposed rule would require that an ad's major statement on side effects and contraindications “be presented in a clear, conspicuous, and neutral manner.” The new rule would require manufacturers to present the information in both the audio and visual components of a video ad and make sure that it isn't overshadowed by other parts of either type of ad. The FDA will accept comments on the proposed rule until June 28.
Restaurants Must Post Calories
As part of the newly approved health care reform law, chain restaurants will be required to post the calorie content for their standard menu items along with information on daily suggested calorie intake from the Department of Agriculture. The provision in the Patient Protection and Affordable Care Act, signed into law last month by President Obama, will affect restaurants and other retail food establishments with 20 or more locations and the same menu items at each location. Restaurants also will need to have additional nutrition information, such as fat and sodium content, available for their menu items. Vending operators with more than 20 machines will be required to post calorie information on their food items. The law requires the FDA to issue proposed regulations by next March.
State Medical Board Actions Up
State medical boards took 5,721 actions against physicians in 2009, an increase of 342, or more than 6%, over 2008, according to a report from the Federation of State Medical Boards. Meanwhile, an analysis by the advocacy group Public Citizen found that the rate of serious disciplinary actions rose slightly in 2009 but still sits about 18% lower than the peak rate of 2004. Minnesota ranked last in disciplining physicians, Public Citizen said, and Maryland, South Carolina, and Wisconsin also consistently rank among the bottom 10. Arizona, Alaska, Kentucky, North Dakota, and Ohio discipline the most physicians, the group said. “There is considerable evidence that most boards are underdisciplining physicians,” Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a statement. “Most states are not living up to their obligations to protect patients from doctors who are practicing medicine in a substandard manner.”
Pfizer Paid $35M in 6 Months
Pfizer, the latest drug manufacturer to disclose payments to physicians, said that it paid approximately $20 million to 4,500 physicians and other health care professionals for consulting and speaking services between July and December 2009. Pfizer also said it paid $15.3 million to 250 academic medical centers and other researchers to fund clinical trials in the last 6 months of 2009. The Pfizer disclosures were required by an integrity agreement that the company signed last year to settle a federal investigation into promotion of off-label uses of drugs. Pfizer is the first major pharmaceutical company to disclose clinical trial payments, although drug maker GlaxoSmithKline has said that it will begin publishing the payments it makes to researchers in 2011.
Broadband Plan Adds Health Goals
As part of the Obama administration's overall National Broadband Plan to extend fast Internet service nationwide, the Federal Communications Commission said it wants to revamp the Rural Health Care Program to ensure that all health care providers have such access. The broadband plan, which contains seven specific recommendations on health care, would redistribute $400 million per year in the Rural Health Care Program to help health care providers purchase broadband services and expand broadband to more institutions. In addition, the new plan calls for states and other regulators to revise licensing, privileging, and credentialing standards to enable physicians to practice medicine remotely and across state lines.
Governor Signs Meth Law
Alabama Gov. Bob Riley (R) has signed a law intended to help law enforcement officials quickly track excessive purchases of pseudoephedrine, the chief ingredient used in the manufacture of methamphetamine. The law creates a new electronic database in an effort to modernize logs that already are kept on paper, making it possible to instantly track excessive purchases of pseudoephedrine. Every pharmacy or retailer selling ephedrine or pseudoephedrine products will be required to enter the purchaser's identifying information into an electronic database prior to any sale. The database then will notify the seller if the purchaser has exceeded the daily or monthly limit for such purchases. Law enforcement authorities also will have access to the database. “Our local law enforcement agencies tell us that in some Alabama counties, meth plays a role in almost every crime,” Gov. Riley said in a statement.