Trump Administration Considers Gulfo as FDA Head Candidate
The Trump Administration has reportedly added Fairleigh Dickinson University professor and executive director of the Lewis Center for Healthcare Innovation and Technology Joseph V. Gulfo to its short list of FDA commissioner candidates. Gulfo has gone on record to urge that FDA and Congress should develop a true conditional approval system similar to the one operating since 2006 in the European Union (see earlier story). He said that a conditional approval process could be available for products where: (1) the benefit/risk balance is positive; (2) it is likely that comprehensive clinical data will be provided; (3) unmet medical needs will be fulfilled; and (4) benefit to public health of immediate availability outweighs risks that additional data are still required. The approvals require annual renewal and can be converted to full marketing authorization upon review of definitive data generated during the conditional approval period.
Gulfo was also critical of FDA last year (see story) in a lengthy and detailed report from the George Mason University Mercatus Center that argued that the agency has strayed from the drug, biologic, and medical device safety and effectiveness standards set out in the law due to “fear of being blamed for the failings of approved products.” The agency now, it said, is applying standards for approval that are based on predicting the benefits and risks — clinical utility, disease outcomes, survival — that an average patient will experience. “But these outcomes are better evaluated in real-world, post-market settings, that is, in the medical marketplace, where knowledge about the value of a drug or device for different types of patients can grow over time,” it argues.
Additionally, Gulfo supports relaxing FDA restrictions on scientific information dissemination by medical product companies (see story). Writing in an online blog, he said that rather than continue to position itself as the sole arbiter of what scientific evidence is true based on a “substantial evidence” standard, FDA should adopt a policy for off-label uses based on the Federal Trade Commission’s “competent and reliable scientific evidence approach.”
He said that FDA’s position is that good medical practice and a patient’s best interests require that doctors use legally available drugs, biologics, and medical devices according to their best knowledge and judgment. “If physicians use a product for an indication not in the approved labeling,” he wrote, “they have the responsibility to be well-informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects.”
For doctors, Gulfo said, one of the biggest problems related to widespread off-label use is the lack of information about how to best use the drug other than for its approved indication. While the drug label is one of the most reliable and easy-to-find sources of information available to health professionals, caregivers, and patients, it can only contain information that has been approved by FDA and thus does not cover off-label uses. He argued that using an FTC-like approach “is an appropriate middle ground.” Applying such a standard would mean that an advertiser must possess at least the level of substantiation expressly or impliedly claimed in an advertisement, such as “tests prove,” “doctors recommend,” or “studies show.” “The level of substantiation depends on the nature of what is being claimed,” Gulfo wrote.