When a health plan makes an unsolicited request for an AMCP-style dossier, the prevailing opinion is that pharma needn’t worry about running afoul of the law Section 114 refers only to direct promotion of pharmacoeconomic information. Manufacturers often include pharmacoeconomic data or modeling in an AMCP dossier. You’ll take away the incentives to do the trials they should be doing if they can promote based only on database studies and models.”Īnother reason for the FDA’s silence may relate to the AMCP’s release of its Format for Formulary Submissions in 2000. Or, he says, the agency’s inaction could stem from “a feeling in certain places that we shouldn’t allow drug companies to promote health economic information outside the clinical trials because they will mislead customers, including managed care. The FDA’s inaction regarding clarifications to Section 114 could stem from a difficulty in drawing fine lines, says Peter Neumann of Tufts Medical Center. ‘Let them figure it out’ - which is kind of what FDA has said in not saying anything.” “It’s hard, and in a way you could argue that the FDA shouldn’t even worry about it, as long as these are companies talking with formulary committees. The FDA could have more pressing priorities, he says, or may recognize the difficulty of drawing fine lines. Why no guidance has been issued after almost 20 years is a matter of speculation, says Peter Neumann, director of the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center in Boston. “From our perspective, the issue is being able to have access to health care economic information that in some cases companies have but aren’t free to give to managed care pharmacy professionals,” says Susan Cantrell, CEO of the Academy of Managed Care Pharmacy (AMCP). In turn, pharma companies, fearful of being penalized for off-label promotion, have erred on the side of caution, hesitating to take advantage of Section 114. In fact, the FDA never issued regulations to clarify the boundaries of promotion of pharmacoeconomic data. The Academy of Managed Care Pharmacy hopes to meet with the FDA soon to discuss clarifying Section 114, says Susan Cantrell, the organization’s CEO. A year after the law was passed, Nancy Cahill, a prominent health care attorney, told a International Society for Pharmacoeconomics and Outcomes Research briefing that “the totally positive spin being put on the new legislation is alarming” and warned pharma to educate the FDA about health economics research or risk facing “regulations that run 180 degrees counter” to the intent of Section 114. But the FDA issued no guidance on how to interpret the law, neutering it from the outset. The act’s much-talked-about Section 114 gave the pharmaceutical industry a safe harbor from the threat of penalties for off-label promotion when sharing economic information with decision makers. But even when manufacturers conduct health economics research, they frequently hesitate to promote it because of legal ambiguities about what they can say and to whom.ĭuring President Clinton’s second term, Congress passed the Food and Drug Administration Modernization Act (FDAMA). As specialty drug costs began to challenge payer budgets and providers took on risk, demand for evidence of pharmacoeconomic value was inevitable. The pharmaceutical industry may be the next frontier. The health care reform law has enabled or inspired so many changes in the infrastructure of American health care - ACOs and integrated delivery systems, federal and commercial quality-incentive programs, and CMS’s alternative payment models - that it’s hard to imagine that we’ll go back to a time when dollars and outcomes traveled in different orbits. Value-based purchasing in health care has reached the point of no return, no matter who wins the White House or if the ACA were to get scrapped.
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