Duo of US Bills Aim to Prevent Drug Shortages, Amend 510(k) Pathway

Posted 03 February 2012 | By Alexander Gaffney, RAC 

Representatives John Carney (D-DE) and Ed Markey (D-MA) both introduced bills this week that would, respectively, aim to prevent drug shortages and grant the US Food and Drug Administration (FDA) the authority to prevent medical devices from claiming substantial equivalence to a recalled medical device.

Carney's bill, the Drug Shortage Prevention Act of 2012, would amend Chapter V of the Federal Food, Drug and Cosmetic Act (FD&C Act) to require FDA to establish, define, keep updated and publish a list of critical drugs and drugs subject to shortages.

FDA would further be charged with expediting review of critical drugs and drugs experiencing a shortage situation, establishing procedures and timeframes for expedited review and improving "the process for regulating critical drugs."

The bill would also give power to the Attorney General to go after drug wholesalers it suspects of stockpiling, price gouging or conducting other "unlawful activities related to the distribution of a critical drug."

Markey's bill, which is co-sponsored by Reps. Henry Waxman (D-CA), Jan Schakowsky (D-IL) and Rosa DeLauro (D-CT), would address medical device safety through changing the use of "substantial equivalence" in 510(k) filings.

The Safety of Untested and New Devices Act of 2012 (SOUND Devices Act)aims to "amend the Federal Food, Drug, and Cosmetic Act to ensure that a medical device is not marketed based on a determination that the device is substantially equivalent to a predicate device that has been recalled, corrected, or removed from the market because of an intrinsic flaw in technology or design that adversely affects safety, and for other purposes."

The SOUND Devices Act would accomplish this by amending Section 513(i) of the FD&C Act to require 510(k) applicants to include the lineage of each device the applicant's device claims as a predicate.

The 510(k) application pathway is used by FDA to clear devices that it believes have already been proven to be safe. This allows manufacturers that have made innovated a new device based on a prior device's design to forgo clinical trials and access the market in an expeditious manner.

The SOUND Devices Act would allow FDA to reject 510(k) applications if the predicate device was or is subject to a recall, correction or removal. FDA is also empowered to require manufacturers to submit reports if a device in the "same lineage" experience flaws. These reports must address whether or not the manufacturer believes their marketed device shares that same flaw, and if not, why.

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