DA Leadership Declares New Public Health Mission for Agency

The 2 physicians who now oversee the FDA want the agency to think of itself less as a regulator and more as a part of the nation’s public health apparatus. In an editorial in the June 11 issue of the New England Journal of Medicine, Margaret A. Hamburg, MD, the new FDA commissioner, and Joshua M. Sharfstein, MD, the new principal deputy commissioner, assert that “establishing the FDA as a public health agency requires a culture that encourages scientific exchange and respects alternative viewpoints along the path of decision making.” They argue that “the ultimate measures of the FDA’s success should reflect its fundamental goals and go beyond such intermediate measures as the number of facilities inspected or drugs approved.” This view is not surprising given their backgrounds: Hamburg served as health commissioner of New York City for 6 years (1991 to 1997), and Sharfstein was filling a similar role in Baltimore when tapped for his FDA post.

In their editorial, Hamburg and Sharfstein explain, “we expect to collaborate with other federal agencies and outside partners to address problems that the agency cannot solve alone.” In an attempt to achieve that goal, they say, “the FDA should provide the data on which it bases its regulatory decisions and other guidance and explain its decision-making process to the public.”

Backing up these objectives, in June Hamburg established an internal task force, headed by Sharfstein, to devise ways to make the agency more transparent. “Some of what emerges from the task force may be very small tweaks to the system, and some may be much more significant changes in how we do business,” she said. Written public comments can be submitted until August 7, and an open meeting on the issues raised by making more data public will be held in the fall. The FDA asked those attending the meeting to address such questions as “How can the agency better explain what it does?” and “What tools should the agency use to provide more useful information?” The task force is expected to issue its final report in early December.

While “small tweaks” could be put in place almost immediately, the type of information that the FDA can release to the public is severely limited by a network of laws, principally the Federal Trade Secrets Act. Enacting legislation to authorize such regulatory changes would “involve more than 1 Congressional committee and impact thousands of companies, and thus would be an extremely difficult legislative path,” explained Peter Barton Hutt, a former FDA general counsel. Some industry opposition is likely. Any changes that might “disclose information about medicines during the FDA review process should be carefully considered to ensure that the competitive development process remains intact,” cautioned Kenneth Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America (PhRMA).

FDA Demands More Emphasis on Risk in Ads
The FDA is getting tougher about what pharmaceutical manufacturers must and must not say in direct-to-consumer (DTC) prescription drug advertisements. The agency maintains that new, or at least more explicit, standards are needed so that manufacturers convey a drug’s potential adverse effects in their ads. According to research findings included in a draft guidance called “Presenting Risk Information in Prescription Drug and Medical Device Promotion,” 60% of consumers believe that current DTC advertising does not provide enough risk information and that the same percentage of physicians find that “patients have little or no understanding from these ads about what the possible risks and negative effects of the products are.” In the document on conveying those risks, released on May 27, the FDA does not change its basic rules but is far more specific about what pharmaceutical companies must include in their ads. “As the amount of benefit information conveyed increases, the amount of risk information conveyed should similarly increase,” according to the draft guidance.

Reviewers examine both the wording and the “net impression” of an ad, the draft guidance explains. “Manufacturers should focus not just on individual claims or presentations, but on the messages conveyed by the promotional piece as a whole.” This means that a television commercial with appropriate language can still be deemed noncompliant if it contains a lot of quick cutting or loud mu- sic that may distract from the words. Simi-larly, a print ad with enough risk information can be cited if that text is displayed in small-er type or if it is in a less prominent position than the information on benefits or if it contains overly technical language (eg, “syncope” instead of “fainting”).

The draft guidance applies to both DTC advertising and advertising aimed at health care professionals, as well as to booklets, exhibits, and Web sites. Comments on the draft are being accepted until August 25.

However, even before the draft guidance is finalized, the FDA has directed its new tough approach toward the existing rules for prescription drug ads. By mid-year, the agency’s Division of Drug Marketing, Advertising and Communications (DDMAC) issued more citations than it had in all of 2008. In addition, because state attorneys general are now more often willing to bring follow-up action after the FDA issues a citation, “the stakes on getting a warning letter are much, much higher than people perceived them to be in the past,” said attorney Arnold I. Friede of McDermott Will & Emery. Warning letters issued on May 19 show that the DDMAC is especially concerned about identifying ads that make claims (even supportable ones about general well-being) for drugs that are not on their labeling and ads that slip all the risk information in at the end.

Medicare Prescription Drug Coverage
PhRMA Ad Campaign Lauds Part D
The PhRMA is launching a promotional campaign “touting the importance and success of free-market initiatives such as the Medicare prescription drug benefit,” the trade association announced on June 10. “There is a success story out there in health care, and we want people to know about it,” explained Kenneth Johnson. “Since its inception, the Medicare drug benefit has given beneficiaries unprecedented access to needed medications at an affordable cost.”

The national television advertising cites a survey that shows that enrollee satisfaction with the Part D program has grown from 78% when it began in 2006 to 84% today. “The Medicare benefit is working, and seniors are happy,” the ads state. Moreover, the PhRMA points out, every state has available at least 1 plan with a premium of $23 or less a month, and 97% of enrollees opting for a stand-alone plan have access to a plan with a 2009 premium that is no more than the premium they paid last year-and in some cases actually costs less. The campaign also touts the wide range of choices available for seniors under Part D, although a recent study funded by the Robert Wood Johnson Foundation found that the more plans seniors have to choose from, the less likely they are to select the most cost-efficient plan or to understand the plan details.

The PhRMA ad campaign is timed to influence the current debate in Washington over the shape of comprehensive health care reform and encourages Americans to back such efforts. “Tell Congress we need quality affordable health care coverage for every American,” the ads exhort. The ads’ subtext is that any reform should emulate the Part D model in which patients have options to choose from, private companies play a major role, and the government does not directly negotiate or set drug prices.

Vermont Enacts Strict Ban on Pharma Gifts
On June 8, Vermont Gov Jim Douglas (R) signed into law what are considered the nation’s most stringent restrictions on pharmaceutical manufacturers’ use of incentives to prescribers. The curbs went into effect on July 1.

While Massachusetts and Minnesota have enacted new restrictions on promotional activities that target physicians, the Vermont measure is far more extensive. It applies not only to physicians but also to pharmacists, nurses, medical staff, administrators of health benefit plans, and institutions that provide health care. The law bans virtually all gifts, including meals, although free drug samples are still allowed. It also calls for complete disclosure of monetary payments made to practitioners for such activities as giving lectures, with annual public reporting of the name of each recipient of such payments and the total amounts received. Payments for taking part in clinical trials are exempted, but only for those being run under the authority of the FDA. Fines of as much as $10,000 per violation are authorized by the statute.

Before the legislation was passed, William H. Sorrell, Vermont’s attorney general, conducted a study that found that in 2008, medical product manufacturers were spending about $3 million a year marketing their products to the state’s 4573 licensed health care practitioners and that close to half of those practitioners (2280) had received some form of payment. Details were lacking, however, because manufacturers described 83% of the payments as related to trade secrets that could legitimately be kept confidential. The new law, which was supported by the Vermont Medical Society, specifically decrees that payments to practitioners cannot be called trade secrets.

In Other Legislative and Regulatory News . . . The Department of Health & Human Services (HHS) has distributed $25 million to 47 states to enable more low-income Medicare beneficiaries to take advantage of subsidies available for Part D coverage. HHS believes that many beneficiaries who would qualify for the financial assistance are unaware of its existence or how to apply for it. Florida, with a $1.5 million grant, received the largest individual state share of the program funding.

The Medicare Payment Advisory Commission (MedPAC) may become much more powerful. Currently, the panel is an arm of Congress, advising the lawmakers on where to set annual Medicare reimbursement levels. But in June, President Obama said he favors shifting the agency into the executive branch. MedPAC’s reimbursement levels would then take effect unless both houses of Congress, in a joint resolution, voted against them.

Walgreens stopped filling Medicaid prescriptions at its 66 outlets in Delaware as of July 6. The move came after the state reduced its payments for brand-name medications. “Quite simply, we can’t continue to participate in a program that, in some case, pays us less than our cost to fill these prescriptions,” explained Kermit R. Crawford, the chain’s senior vice president of pharmacy. Delaware Gov Jack Markell (D) said that in response he would consider ending the state contract that allows workers covered through the state’s civil service insurance program to fill prescriptions at Walgreens’ Happy Harry’s pharmacies.