FDA bill expands off-label promotion
Compounding, speed to market not big issues
The new U.S. Food and Drug Administration overhaul bill, or reform bill, as it’s also called, has been promoted as a way to speed up the drug approval process. But the bill has many elements, including the extension of the established user fee system allowing drug companies to fund FDA drug review, already used for that purpose. The bill also expands the FDA’s experimental or compassionate use protocols, adds incentives for the development of pediatric drugs, and speeds up the processes for medical devices. For most pharmacists, the bill’s effect on compounding vs. manufacturing and the expansion of off-label promotion by drug companies are most important.
Aggressively lobbied by the Community Retail Pharmacy Coalition, language included in the original bill by Sen. Tim Hutchinson (R-AZ) would have ensured that individual states, and not the FDA, would hold regulatory powers over pharmacy compounding. A long-standing issue has been the FDA opinion that some pharmacy compounding was, in effect, manufacturing and therefore under the agency’s regulation. But the agency had not been pursuing that oversight, and the original Congressional bill did not include any language on compounding.
Seizing the opportunity, the coalition made up of the National Association of Chain Drug Stores and the National Community Pharmacy Association successfully had the language included to keep compounding out of the FDA’s hands and instead under the purview of the states. The language also was supported by the American Pharmaceutical Association and the American Society of Health-System Pharmacists, among others. It specifies the FDA will not have the authority to determine whether a "medical need" exists for a compounded drug, prevents the FDA from regulating any compounding oversight brought by a state, and sets up the means to establish an accepted list of substances that can be used for compounding.
The FDA bill will allow drug manufacturers to market technically unapproved off-label uses for their drugs directly to pharmacists, physicians, and insurers. Doctors now are free to prescribe drugs off-label individually or as combinations, based on their own findings or through medical literature. The bill would allow drug makers to send unsolicited information from medical journals directly to health care professionals.
Historically a way for drug makers to sell drugs for additional uses without another expensive approval process, off-label promotion itself is nothing new. What’s debatable is whether this bill will open a floodgate to unethical practices or simply confuse health care professionals.
Steven Cano, PharmD, director of pharmacy at Fallon Healthcare Systems in Worcester, MA, sums up the issues posed by many pharmacists this way: "There is a potential for good and bad. Clearly drugs are used off label. That’s a given, and it can be understandable that the manufacturers feel it’s unfair not to be able to talk about that, but the worry is by freeing up their ability to speak, will that let them get into conjecture vs. fact on what is research and what is not?
"We may not have a vested interest in their profits and loss but our own cost benefits. To us, whether a drug has an FDA-approved indication is not always important if there is a sufficient body of literature to support a therapeutic arena. The standard of practice will move beyond what is or is not FDA approved, but the fear is that whether taking the handcuffs off will fall into what’s good science vs. what’s conjecture. The intention of drug makers is to move market share," he says.
That intention does have a dark side, as shown in a lawsuit filed by former employees of Rhone-Poulenc Rorer in Collegeville, PA, centering around the company’s heparin blood thinner, Lovenox. The plaintiffs allege the company paid a doctor to push its drugs during a company-funded lecture series and that the company pushed sales reps into criminal off-label promotion schemes. And finally, the former employees allege the company directed them to alter documents an effort they say took eight months that would validate the off-label directives and memos to sales staff.
No example of off-label promotion, and moreso off-label prescribing, has been as chilling as the fallout and recall of the unapproved diet pill combination called fen-phen. While Pondimin (fenfluramine) and Redux (dexfenfluramine) have been recalled based on the occurrences of heart valve disorders in those taking the drugs, phentermine was not recalled and remains a viable diet drug.
With millions of Americans embracing the drug, physicians prescribing it, and hospitals pushing to establish fen-phen clinics, scientific studies of the drugs, either singularly or as a combination, got lost in the shuffle. Shortly after the FDA announced its recall of fen-phen, the agency also warned the makers of herbal fen-phen to stop marketing the dietary supplement as a weight-loss product, because consumers were flocking to it.
For pharmacists, the challenge is unclear. How should they have responded to a popular craze like fen-phen, or for that matter, how should they respond to the next diet pill craze as off-label promotion and drug approval expands? "The profession tends to be dialed into certain issues and not dialed into other ones," Cano says. "If you want to talk about AIDS or MI, cancer, and other kinds of diseases with direct patient care involvement, what you’re really talking about was a cosmetic concern. If I had to define my areas of therapeutic interest it’s probably much more about cancer and heart disease more than weight control.
"As pharmacists, we dial into things we feel we can make a difference in," Cano says, offering a frank assessment that’s clearly a caveat emptor in terms of diet pills and the FDA reform bill itself. It’s also a sentiment shared by other pharmacists quizzed on the issue.
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