In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The healthcare industry has heralded this announcement as a positive step in a regulatory environment that, many believe, provides unclear direction regarding the provision of truthful information to healthcare providers, leaving industry players vulnerable to FDA regulatory enforcement, criminal prosecution, and civil suits under the False Claims Act ("FCA").
While the FDA’s announcement was welcomed by many after years of uncertainty and after recent events raised new questions about the constitutionality of the ban on off-label promotion, questions remain about the ultimate effect of the FDA’s decision. First, will the agency provide clear statements regarding the scope of lawful and unlawful off-label promotion, or merely restate existing policy? Other agencies, including the Federal Trade Commission ("FTC") and the Securities and Exchange Commission ("SEC") have been criticized for issuing "new" guidance documents that simply restate the same ambiguous advice that prompted the industry to request their issuance. The FDA has not provided any indication of what its draft guidance will say, and in the absence of an accompanying revision to applicable regulations, it is difficult to predict whether the FDA’s guidance will provide clear advice to the pharmaceutical and medical device industries.
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