American College of Cardiology

House Expected to Vote on Tobacco Bill

The House is expected this week to vote on the “Family Smoking Prevention & Tobacco Control Act” (H.R. 1256), which would grant the Food and Drug Administration (FDA) authority to regulate tobacco products. The bill would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to grant the FDA the authority to restrict tobacco marketing and sales to youth; require detailed disclosure of ingredients; allow FDA to require changes to tobacco products; and require larger, more specific health warnings. The FDA activity would be funded by a user fee on cigarette manufacturers, allocated by market share.

The ACC highly encourages members to contact their lawmakers in support of this important. Please call the tool-free Capitol Switchboard at (202)224-3121 to be connected to your lawmaker.

ACC Holds 58th Annual Scientific Session

The ACC from March 29-31 held its 58th Annual Scientific Session in Orlando, Fla. The event featured exciting science, quality improvement programming and a health care reform call-to-action for members. Complete coverage of the meeting is available online from ACC.09’s newspaper, Scientific Session News. Click here to view the highlights from the meeting. Also, visit ACC’s online forum, The Lewin Report, for additional coverage of the event, as well as interactive polls and links to the meeting’s posts on Twitter, a real-time messaging service.

Op-Eds Address Health Reform, Industry Relationships
The Detroit Free Press on March 23 featured an opinion piece by immediate-past ACC president, W. Douglas Weaver, M.D., M.A.C.C., on the subject of industry relationships. “The pharmaceutical and medical device industry traditionally has supported physician education by funding some of the costs of scientific meetings and training materials,” he writes. “Removing that support would reduce the amount of needed quality education, restrict medical research and impair scientific publications.” According to Weaver, “industry needs physicians” and “physicians need education.” Click here to read the full article.

Meanwhile, the Orlando Sentinel on March 29 featured an opinion piece by ACC CEO Jack Lewin, challenging physicians to “take ownership” of the health care system and “be stewards for needed reforms.” The op-ed stresses that to fix our “terribly broken” system, “we must institute a outcome-based, pay-for-performance system in which doctors, hospitals and medical systems are held accountable for not just procedures and process, but for patient results.” However, Dr. Lewin notes that implementing this system “is not without obstacles” for physicians, payers and the public. The opinion piece is available online.

FDA News Updates
Medtronic and the Food and Drug Administration (FDA) have issued a Class I recall of the BioGlide and Innervision Ventricular Snap Shunt Catheters due to the possibility that the catheter may become detached from the snap base assembly after implantation and may require emergency corrective surgery. The recalled product was distributed from April 29, 2004 through December 12, 2008. More information is available here.

Watson Pharmaceuticals and the FDA have issued a recall of one lot Propafenone HCL 225 mg tablets because some tablets may contain slightly higher levels of the active ingredient than specified. Due to its narrow therapeutic index, some patients who are particularly sensitive to small variations in doses may experience potentially serious side effects, including arrhythmias or low blood pressure. The affected lot of tablets was shipped to customers between October 15, 2008 and November 26, 2008. Click here for more information.

Caraco Pharmaceutical Laboratories and the FDA have issued a consumer-level recall of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September 2011. The tablets may differ in size and therefore could have more or less of the active ingredient, digoxin, a drug product used to treat heart failure and abnormal heart rhythms. Consumers should return these products to their pharmacy or place of purchase. For more information, click here.