Pushing Off-Label Drug Use

Before a company can bring a new drug to the market, a drug must first go through the Food and Drug Administration approval process. The pharmaceutical industry complains that the FDA process is too strict. But just last year the Institute of Medicine reported that the FDA’s drug safety monitoring was inadequate. The FDA responded by initiating some reforms earlier this year and has slowed the pace of drug approvals compared to last year. But the FDA’s own Science Board recently reported that the agency still doesn’t have the capacity needed to adequately protect the public:

A loss of scientific expertise at the Food and Drug Administration is threatening American lives, advisers to the embattled consumer protection agency conclude in a report released Friday. [...]

 

FDA Commissioner Andrew von Eschenbach requested that the agency’s Science Board, his own outside advisers, probe the problems.

 

The Science Board subcommittee given the task was blunt: “In contrast to previous reviews that warned crises would arise if funding issues were not addressed, recent events and our findings indicate that some of those crises are now realities and American lives are at risk.” [...]

 

Congress has enacted 125 statutes giving the FDA new or expanded responsibilities since 1988, without enough funding to cover the extra work, the report said. The FDA has about the same number of employees today as 15 years ago, and its budget has lost the equivalent of $300 million to inflation.

 

At the same time, increasingly sophisticated scientific expertise is required to oversee increasingly complex medical therapies and imported foods. The report found FDA is unable to recruit and retain leading-edge scientists in key areas and now has a turnover rate twice that of other government agencies.

 

The report cites an Institute of Medicine estimate that the $1.8 billion FDA budget needs a boost of at least $350 million to address drug safety[.]

It is troubling that the agency regulating drug safety isn’t sufficiently up to the task. Also troubling is the agency’s apparent interest in promoting off-label uses. An off-label use is a use of an FDA-approved drug for which the FDA did not review safety and efficacy. As most of us know, plenty of drugs are prescribed for off-label uses. However, companies aren’t allowed to market unapproved uses.

While it is legal for physicians to prescribe drugs or use medical devices in ways not specifically approved by the FDA, companies that make the products aren’t allowed to market such practices. A number of drug makers have been prosecuted for allegedly pushing to increase “off-label” use.

 

According to a draft of the proposal, the FDA is considering guidelines that would say manufacturers may give doctors articles from medical journals and materials drawn from scientific reference texts that discuss off-label uses of drugs and medical devices.

Rep. Henry Waxman is opposing the proposed guidelines:

In a letter to the company, he wrote that articles in medical journals may provide “a distorted picture of a drug’s safety or effectiveness,” because journal editors may not know the full story behind a study — such as whether its design was changed, or if negative results were left out of an article.

Not to mention that peer reviewers for medical journals are often paid by drug companies. Some journals have responded to recent publicizing of this fact by increasing the strictness of their disclosure requirements, but by and large they don’t ban articles authored by people with financial ties to the industry.

Prescription drug use is one of the fastest growing areas of health care. To some degree, that’s a good thing. Effective use of prescription drugs can prevent, delay or minimize the need for costlier types of care (such as hospital use). But inadequate safety and efficacy review, whether due to lack of capacity at the FDA or because companies prefer to push sales up at less cost by not submitting a use to FDA scrutiny, can have serious consequences for people’s health. It also has financial consequences, when people end up in the hospital or require other health care services due to an inadequately-tested drug.