The FDA Safety and Innovation Act: Much More Than Just User Fees

With almost no fanfare, President Obama signed the FDA Safety and Innovation Act (SIA) into law earlier this month. The popular and legal media coverage of the bill leading up to its enactment seemed to focus on the reauthorization of user fees for prescription drugs and medical devices and the creation of new user fees for generic drugs and biosimilars. As usual, the user fees are accompanied by performance goals for the FDA’s review of the related applications. But the SIA also contains a host of other provisions relating primarily to drugs and medical devices.

With respect to medical devices, § 601 of the SIA precludes the FDA from refusing to approve an Investigational Device Exemption simply because it determines that the proposed study alone will not support an approval to market the device. Section 602 refines the “least burdensome” provisions to specify that FDA can only request the “minimum required information” to support clearance or approval to market a device. Section 603 requires the FDA to document the rationale for “significant decisions” in connection with IDEs, 510(k)s, and PMAs.

Section 604 requires FDA to withdraw a draft guidance on when a modification to a device requires a new 510(k) and to submit a report to Congress on a new approach. FDA may not issue a new guidance until at least 12 months after it submits the report. Other sections require FDA to improve the device recall program, authorize clinical holds on IDEs, allow a sponsor to seek a de novo classification directly rather than only after pursuing a 510(k) and receiving a “not substantially equivalent” determination, allow FDA to reclassify a device category by administrative order, reauthorize third-party reviews and inspections, revise the Humanitarian Device Exemption to allow a manufacturer to make a profit in more circumstances, require FDA to issue a proposed rule for a unique device identification system (which it recently has), expand the drug “Sentinel” system to medical devices, add timing requirements to post-market surveillance orders, and revise the definition of a “custom” device, among other changes.

The SIA makes many changes to the regulation of drugs also. Similar to the unique device identification system, FDA must create a unique facility identification system for drug facilities and maintain an electronic database of their registration and listing information. A drug is now adulterated if it is made, packaged or stored in a facility that delays, denies, or limits an inspection. The biennial inspection schedule for drug facilities will be replaced with a “risk-based” system. FDA may require manufacturers to furnish records in advance of an inspection. FDA now has ex-US jurisdiction over any violation of the Food, Drug & Cosmetic Act (FDCA) related to an article to be imported into the US. FDA may require an importer to submit records in advance of importation showing compliance with the FDCA. FDA now has authority to detain drugs an inspection reveals may be adulterated or misbranded.

The SIA makes permanent the Best Pharmaceuticals for Children Act and its six months of marketing exclusivity in exchange for conducting pediatric studies. It also makes permanent the Pediatric Research Equity Act which requires pediatric studies for most drugs and biologics. The SIA also includes several provisions to encourage the development of antibacterial and antifungal products, including an additional five years of marketing exclusivity for a product designated by FDA as a “Qualified Infectious Disease Product.”

Other drug-related provisions include § 901 which expands the products that qualify for fast track review and the endpoints that may be used to gain fast track approval. Section 902 allows FDA to accelerate approval of “breakthrough therapies” defined as those which may show “substantial improvement over existing therapies on one or more clinically significant endpoints.” The SIA requires FDA to “implement a structured risk-benefit assessment framework in the new drug approval process.” It creates a “priority review voucher” as an incentive to develop treatments for rare pediatric diseases.

The SIA includes provisions designed to mitigate the recent drug shortages. Manufacturers are required to notify FDA at least six months, or as soon as is “practicable,” before they discontinue or interrupt manufacture of a particular drug to an extent that may cause a disruption in supply. FDA must consider the impact of any warning letter or other enforcement action on the supply of a drug. FDA must create a task force to develop and implement a strategic plan to prevent and mitigate shortages. The Comptroller General must study drug shortages and their causes.

The SIA contains several miscellaneous provisions as well. Within two years, FDA must issue a guidance on the use of the internet (including social media) to promote regulated products. FDA is to work with regulators from other nations to develop uniform, scientifically driven clinical trial standards. FDA is to research the use of nanomaterials in regulated products. FDA cannot further delay the effective date of its final rule on over-the-counter sunscreens. The SIA clarifies and modifies the time frame within which an ANDA must receive tentative approval to avoid forfeiting the 180 day marketing exclusivity. The time for FDA to respond to certain citizen petitions related to generic drugs and biosimilars is shortened from 180 to 150 days. There are changes to the conflict of interest rules for FDA advisory committees.

The SIA contains other provisions, as we have mentioned only those we thought most likely to be of interest. Anyone subject to FDA regulation may wish to investigate the act, which can be found here, more thoroughly for items of potential relevance to their business.