Easing Use of Experimental Drugs
The Food and Drug Administration is proposing to widen access to experimental drugs. The agency has been accused by patient advocates and some drug makers of obfuscating the criteria physicians need to seek to use investigational drugs in their patients. In 2003, an Arlington, Va.-based advocacy group, the Abigail Alliance, sued the FDA to get unfettered access to unapproved therapies. The plaintiffs were backed by a federal appeals court in May 2006, and a rehearing of the case is expected to begin in March. In the meantime, the FDA's proposed rule, published on Dec. 14, said the agency was going to make it easier for physicians to access experimental therapies, and for manufacturers to make them available. “FDA hopes this proposal will increase awareness in the health care community of the range of options available for obtaining experimental drugs for seriously ill patients,” Dr. Janet Woodcock, FDA deputy commissioner for operations, said in a statement. A separate proposed rule would make it easier for manufacturers to recover costs. In a statement, the Abigail Alliance said the FDA proposals “merely clarify their existing policies.”
Stem Cell Support Drops Slightly
Most of the public supports the use of human embryonic stem cells for medical research, but that support may be faltering slightly, according to a new poll from Virginia Commonwealth University, Richmond. The survey, which included 1,000 adults, found that 54% of respondents favored stem cell research in 2006, down from 58% in a similar VCU poll in 2005. The number of respondents who opposed stem cell research climbed from 32% in 2005 to 37% in the recent 2006 survey. However, when asked if they would support the use of embryonic stem cells to find a treatment for themselves or a family member with Parkinson's disease or spinal cord injury, 70% of respondents said yes. Only 21% would not support the use of stem cells in that situation, according to the 2006 poll.
Lax Enforcement of Ad Regulations
FDA issued fewer violation letters regarding direct-to-consumer drug advertising during 2002–2005 than it did in previous years, the Government Accountability Office reported. Further, FDA took longer to send such letters to drug manufacturers, said the watchdog agency, pointing out that the industry spent $4.2 billion in 2005 on DTC advertising. Such advertisements can be positive—by encouraging consumers to talk to physicians—but can also increase spending on the advertised drug and other drugs to treat the same condition, said the GAO in its December report. GAO said that it took 4 months for the agency to draft, review, approve, and issue a letter in 2002–2005, compared with 2 weeks during 1997–2001, and that it issued 8–11 letters a year, compared to 15–25 previously. Though drug companies often complied with orders to cease and desist, sometimes the manufacturers would later put out similar violative materials for the same drugs, said the GAO. The GAO said it had noted in a previous report in 2002 that the FDA's violation letter process was being delayed by internal reviews. That has not improved, according to December's report, which recommended that FDA set criteria for prioritizing advertisements for review, systematically apply the criteria, and track materials reviewed.
NYC Bans Trans Fat
In a move aimed at improving the healthfulness of restaurant food, the New York City Board of Health recently voted to require that all of the city's restaurants remove artificial trans fats from foods by July 2008. The mandate gives restaurants until July 1, 2007, to switch to oils, margarines, and shortenings that have less than 0.5 grams of trans fat per serving; by July 1, 2008, all other food items sold in restaurants must meet the same mark. New York is the first city to make such a move. The move was praised by the American Diabetes Association: “When you consider that many American adults—and their children—are eating out several times a week, it is even more difficult to avoid trans fats and maintain a healthy diet,” said Dr. Peter Sheehan, president of the American Diabetes Association's New York City Leadership Council. “For more than 700,000 New York City adults diagnosed with diabetes, the passage of this proposal eliminates a major source of artificial trans fats and should serve as a model for other cities to consider.” In testimony in 2006 before the New York City Board of Health, the New York State Restaurant Association said that although the measure is well intentioned, it will not achieve the health benefits being sought. The 18-month transition does not give restaurateurs enough time to find healthful alternatives, the group said. Many will end up returning to the use of oils high in saturated fats.