FDA Warns Lilly on Adcirca Promos
The Food and Drug Administration has issued a warning to Eli Lilly & Co. and United Therapeutics that a Web page and two patient videos were in violation of the agency's promotional rules. Adcirca (tadalafil) is indicated for pulmonary arterial hypertension to improve exercise ability. The FDA cited the Web page for failing to include any contraindications, warnings, or precautions for the drug, which “misleadingly suggests that Adcirca is safer than has been demonstrated,” said the warning letter. The two patient videos “seriously misrepresent what is known about the efficacy of Adcirca,” said the FDA. The agency directed the drug makers to immediately cease dissemination of the offending materials.
ICD Study Collaboration
The Agency for Healthcare Research and Quality (AHRQ) and the American College of Cardiology are joining on a $3.5-million project to study the long-term benefits and risks of implantable cardioverter defibrillators in patients at risk of death from ventricular fibrillation. The three-and-a-half-year study will be carried out by a network of 15 health care delivery systems and is being led by Dr. Frederick Masoudi of Kaiser Permanente Colorado and Dr. Robert Greenlee of the Marshfield (Wisc.) Clinic Research Foundation. The network is supported by the AHRQ. Over the first 2 years, 3,500 patients will be followed to determine how often shocks are delivered and if they are appropriate, and to determine who is most likely to require defibrillation. In the final year, the data will be analyzed.
No FDA Conflict on Heparin
The FDA revealed in early February that a federal investigation had cleared Dr. Janet Woodcock of any conflict-of-interest allegations over her involvement with Momenta Pharmaceuticals, a company that was seeking approval for a generic version of Lovenox, a low-molecular-weight heparin. In an ethics complaint filed in mid-2009, Amphastar Pharmaceuticals claimed that Dr. Woodcock, director of the FDA's Center for Drug Evaluation and Research, was biased in favor of Momenta because she had worked with the company in investigating the tainting of Chinese heparin. Now, the Inspector General of the Department of Health and Human Services has ruled that there was no conflict. The controversy aside, Wall Street analysts at Rodman & Renshaw say they predict that Momenta's generic will win approval in this quarter.
PQRI Reminder
In 2010, the Physician Quality Reporting Initiative (PQRI) will include several new measures on coronary artery disease and heart failure. To qualify for the 2% bonus, physicians have to report on only 30 patients. In the past, they had to report on 80% of eligible patients, according to the American College of Cardiology. In addition, there are five individual measures that can be reported through a registry. Cardiologists can use the ACC's Pinnacle Registry (formerly the IC3 Program) for PQRI reporting.
New York Limits Its Salt
The New York City Health Department said it will ask restaurants and producers of packaged food to voluntarily reduce sodium in their meals and products by 25% over 5 years in an effort to curb high blood pressure and heart disease. The department acted as leader of the National Salt Reduction Initiative, a partnership of cities, states, and health organizations. The New York agency said that nearly 80% of the sodium in Americans' diets is added to foods before they are sold. After a year of consultation with food industry leaders, the coalition has developed targets for salt reductions in various foods. In a statement following the New York announcement, Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention, endorsed such efforts: “The majority of Americans are consuming about twice the recommended limit of sodium each day, and not by choice. Achieving substantial reductions in sodium levels by incremental decreases in sodium content across the food supply can save many lives while maintaining good taste.”
No Smoke, No Device Authority
The U.S. District Court for the District of Columbia ruled that the Food and Drug Administration does not have the authority to regulate so-called e-cigarettes (electronic cigarettes) as a drug-device combination. E-cigarettes are battery-powered devices that deliver vaporized doses of nicotine to be inhaled. The FDA had detained multiple shipments of e-cigarettes imported by one company, Smoking Everywhere, saying that they were unapproved drug-devices. Judge Richard J. Leon disagreed with the FDA's justification for its action. However, he did not address whether the agency has authority to regulate e-cigarettes under the Family Smoking Prevention and Tobacco Control Act, which President Obama signed into law last June, after the e-cigarette shipments in this case had been halted.