‘Cures’ Bill Triggers Concerns That Speedier Drug Approvals Could Compromise Patient Safety
Meanwhile, Reuters reports on a recent ruling regarding off-label drug marketing.
FDA Feels Opposing Tug Of Cures Bill, Consumer Safety
Officials at the Food and Drug Administration, worried about legislative initiatives to spur the development of new cures and devices, likely face two years walking a tightrope between lawmakers eager to speed up product approvals and consumer advocates concerned that could weaken important safeguards. The officials can take heart that the House's final bill reflected some FDA concerns. The agency will next turn to a Senate legislative effort expected to run into 2016. Whatever the outcome, it could become the marker for the must-pass reauthorization of the FDA user fee program in 2017. (Adams, 8/10)
FDA Can't Sue Drug Company For Truthful Off-Label Marketing
The U.S. government made a fateful decision in January 2013 when it opted not to seek U.S. Supreme Court review of the 2nd U.S. Circuit Court of Appeals’ 2012 ruling in U.S. v. Caronia, which overturned the conviction of a pharmaceutical sales representative engaged in off-label marketing of a narcolepsy drug. The 2nd Circuit, in a split decision, held that as long as drug companies stick to truthful and accurate statements, off-label marketing is protected commercial speech under the First Amendment and Supreme Court precedent in Sorrell v. IMS Health. Commentary at the time called Caronia a landmark holding that might limit the Food and Drug Administration’s ability to police drug misbranding, but – perhaps fearing a loss at the Supreme Court – the Justice Department and the FDA portrayed the 2nd Circuit ruling as a narrow decision that wouldn’t affect enforcement. That now seems to have been an overly optimistic depiction of Caronia. (Frankel, 8/10)