Medical Device Daily Washington Editor

FDA recently clarified its regulations for promotions of drugs and devices for off-label uses, an area that has been the source of controversy for some time.

In response, Rep. Henry Waxman (D-California), chairman of the House Oversight and Government Reform Committee, sent a 12-page letter to FDA commissioner Andrew von Eschenbach, MD, urging him to "refrain from going forward with this ill-advised guidance."

According to the guidance, the Food and Drug Modernization Act of 1997 (FDAMA) "described certain conditions under which a drug or medical device manufacturer could choose to disseminate" information about off-label use to insurers, pharmacy benefits managers and "others." However, the relevant portion of FDAMA "ceased to be effective on Sept. 30, 2006," hence the guidance.

On the use of reprints of journal articles, the guidance says that any such article must be published by "an organization that has an editorial board that uses experts who have demonstrated expertise in the subject of the article ... who are independent of the [publishing] organization." Any such publications should not be "primarily distributed by a drug or device manufacturer, but should be generally available" and should "address adequate and well-controlled clinical investigations."

According to the guidance, any such releases should "be in the form of an unabridged reprint, copy of an article or reference publication" and may "not be marked, highlighted, summarized or characterized by the manufacturer in any way." The article also cannot be "accompanied by the approved labeling for the drug or medical device."

Off-label promotions were the subject of a lawsuit filed by the Washington Legal Foundation (WLF; Washington), against the Department of Health and Human Services in 1999. In that case, Judge Royce Lamberth of the U.S. District Court for the District of Columbia ruled that FDA's restrictions on the use of peer-reviewed articles and activities in continuing medical education courses were unconstitutional.

Waxman's letter to von Eschenbach acknowledges that "this area of law is complex and that FDA needs to respect the First Amendment rights" of industry, but Waxman argues that, in his view, the guidance "would open the door to abusive marketing practices" that would pose a hazard to public health, citing the cases of the arthritis treatment Rofecoxib (Vioxx) and several others as examples.

Waxman said that one of the problems with peer-reviewed articles is that reviewers "almost never receive the study protocol" and hence "cannot tell what the initial hypothesis was or whether the final analysis represents the planned analysis" because of lack of access to "the underlying data."

Waxman contends that the guidelines "appear to be an effort by FDA to displace Congress and establish by administrative fiat a new system for use of journal articles that lacks the safeguards set by Congress."

The letter says that tracking off-label promotion would be a demand on FDA resources and asked von Eschenbach how many full-time equivalent employees the agency would need to monitor compliance.

No hearings are scheduled in Waxman's committee to investigate this, according to the committee website.

Pilot project offers HSAs with subsidies

Insuring those who have a difficult time affording conventional healthcare coverage has prompted a number of state initiatives, and the Dtate of Indiana has jumped into the fray with a pilot project designed to provide affordable insurance to families making 200% of the federal poverty income level.

Michael Leavitt, the Secretary of Health and Human Services reported last week the implementation of the Healthy Indiana Plan (HIP), with the pilot project designed to make coverage affordable for 120,000 Indianans currently covered by Medicaid and the state's version of the Children's Health Insurance Plan. Contributions to the plan, which resembles a healthcare savings account (HSA), are capped at 5% of family income. Individuals making up to $20,420 and families of four making up to $41,300 are eligible.

In the Dec. 14 statement, Leavitt describes HIP as "a forward-thinking plan to reduce the numbers of uninsured Indiana residents," and he lauds Indiana's governor, Mitch Daniels "for leading such important healthcare reform in the state of Indiana."

Leavitt also says that HIP is "an excellent example of what can be done now in the states to advance" the availability of healthcare insurance.

Daniels said in the statement that state officials are "glad the Department of Health and Human Services and Office of Management and Budget gave us approval for this program in a matter of months," characterizing the plan as "a big step forward that will lead to approximately 120,000 uninsured Hoosiers having the peace of mind of health insurance."

HIP will function as a high-deductible account that will be subsidized by the State of Indiana, with the contribution by the insured to be determined via a sliding scale capped at 5% of annual income. For an individual making $20,000 a year, this comes to $1,000.

The funds can be rolled over to the next year to put toward that year's minimum contribution so long as "age-appropriate preventative services are obtained."