Trump Signs User Fee Reauthorization Bill

President Trump has signed the FDA Reauthorization Act of 2017 that renews the agency’s user fee programs for another five years. Enacting the measure into law removes the threat of having to send reduction-in-force (RIF) notices to staff who are funded by user fees. In late July, the agency postponed the notices while the bill crept though Congress.

In a 8/21 blog post, FDA officials said the new law provides critical support for important activities related to medical product regulation, including: 

• Enhancing its ability to capture the patient voice in drug development.
• Allowing FDA flexibility to inspect medical device facilities based on risk, enabling the agency to focus its resources where they are most needed, while providing greater predictability and transparency to the inspection process.
• Providing FDA with new authority to require a pediatric investigation into an adult cancer drug if that drug is directed at a molecular target that is relevant to a pediatric cancer.
• Providing resources for the popular, highly successful, and resource-intensive breakthrough therapies program for drugs.
• Continuing to leverage the use of “real-world” health data to inform regulatory decision making, including enhancing the capabilities of FDA’s Sentinel system for drugs.
• Establishing a flexible and more efficient path to market for certain new medical device accessories, to enable new and innovative accessories to come to market more rapidly and enable accessories to be used with a wide range of devices – creating important options for patients.
• Creating a category of over-the-counter hearing aids which will help lower costs and enable access for patients who need these devices.
• Providing new opportunities for early consultation on the use of new surrogate endpoints.
• Streamlining combination product review to enhance coordination and transparency between FDA and industry.
• Improving FDA hiring and retention efforts including a dedicated unit for scientific staff and continuous independent assessment of the agency’s hiring and retention operations.

One significant change, according to a new Hogan Lovells analysis under the law will require the agency to consider the views of patients in the medical product development and approval phases and to publish a statement following the approval of an NDA/BLA that describes the patient experience data, if any, submitted and reviewed as part of the application. The patient experience provision calls for data on the impact (including physical and psychosocial impacts) of the subject disease or condition, or a related therapy or clinical investigation, on patients’ lives. “The change appears to clarify, or possibly expand, the scope of data that FDA should be considering when looking at patient experience data,” the law firm says. “The new language clarifies that patient experience data should not be limited to physical impacts of a disease or therapy, but they should also include psychosocial impacts. In addition, the data should not only consider other approved therapies, but they should also include investigational procedures currently in use. Read broadly, the language encourages FDA to consider a broad scope of patient experience data as part of the review process.”