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HHS pushes through last-minute policies impacting FDA

Posted 12 January 2021 | By Michael Mezher 

HHS pushes through last-minute policies impacting FDA

With just days remaining before the transition to a new administration, the Department of Health and Human Services (HHS) is pushing through policies that could impact the US Food and Drug Administration’s (FDA) regulatory oversight.
 
Last week, HHS announced it had finalized a rule that would cause its regulations to expire if they are not reviewed every 10 years, with some exceptions provided for medical device-specific regulations, food standards and over-the-counter drugs, among other carveouts.
 
HHS also announced on Monday that it was issuing two new policies aimed at lifting premarket review requirements for some medical devices and imposing reporting requirements on FDA pertaining to its review timelines for drugs.
 
Notices pertaining to all three policies were posted to HHS’ website with a disclaimer stating that the documents had been submitted to the Office of the Federal Register for publication but have not yet been published in the Federal Register.
 
SUNSET Rule
 
HHS first proposed its Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule in November, allowing just one month for public comment, and held a public hearing on 23 November to gather input on the rule.
 
At its core, the rule would sunset most HHS regulations after 10 years if they are not assessed and reviewed based on criteria set out in the Regulatory Flexibility Act. Initially, the rule gave HHS sub-agencies two years to assess and review affected regulations, though the final rule extends the timeline to five years and exempts certain regulations from the review requirements. The final rule also allows the HHS secretary to extend the review deadline for regulation by up to one year and requires the department to publish monthly lists of the assessments and reviews it has begun for public comment.
 
Participants in the November public hearing raised numerous legal and practical issues with the proposal and pointed out that HHS has existing mechanisms to review and sunset its regulations without needing to resort to automatically sunsetting regulations after a set amount of time. In the public comment portion of the hearing, commenters called the proposed rule “unprecedented,” “arbitrary,” “illegal” and said that it would result in regulatory “chaos” if implemented.
 
Many commenters questioned the timing of the rule and called on HHS to focus its attention on the ongoing COVID-19 pandemic.
 
In a statement announcing the final rule, HHS Secretary Alex Azar said that finalizing the rule “will deliver for the American people better, smarter, less burdensome regulations in the years to come,” while HHS Chief of Staff Brian Harrison said the rule “will prove the boldest and most significant regulatory reform ever undertaken by the federal government.”
 
510(k) exemptions
 
In a separate notice, HHS says it will permanently waive premarket notification (510(k)) requirements for seven Class I medical devices and proposes to waive such requirements for another 84, mostly Class II devices, that were temporarily exempted from premarket review requirements during the COVID-19 public health emergency.
 
HHS says it is looking to exempt the devices pursuant to Executive Order No. 13924, which instructed the heads of federal agencies to “review any regulatory standards that they have temporarily rescinded, suspended, modified, or waived during the public health emergency” to determine whether extending such actions would speed economic recovery and the 21st Century Cures Act.
 
All seven of the devices that are to be immediately exempted from 510(k) notification requirements are gloves. The remainder include a range of devices subject to FDA temporary enforcement policies during the pandemic, including personal protective equipment, imaging systems, thermometers, ventilators and infusion pumps.
 
Drug review timelines
 
HHS is also looking to require FDA to publish information on its timeline for reviewing drug product applications, claiming that the agency often fails to do so within the 180 days called for in the 1962 Kefauver-Harris Amendments.
 
The requirement, billed as a transparency measure, raises questions because the agency has not routinely adhered to the 180-day review timeline established by the Kefauver-Harris Amendments since before the 1992 Prescription Drug User Fee Act (PDUFA). FDA’s current new drug review program aims for a 10-month standard review and a six-month priority review for new drug applications (NDAs) on top of the 60-day window the agency has to file an application following its submission. For generic drugs, FDA aims for 10-month reviews for standard original abbreviated new drug applications (ANDAs) and 8-month reviews for certain priority original ANDAs.
 
In its notice, HHS says it will require FDA to publish an annual notice for each approved NDA and ANDA stating the date FDA filed or received each application and the date on which they were approved, as well as the days elapsed and the days in excess of 180.
 
HHS also conducted a review of new drugs approved in 2019 and unsurprisingly found that most were reviewed in more than 180 days.
 
“The Department found that 38 of the 48 drugs (79.1%) were approved more than 180 days after submission of an application. The average time from submission to approval for the 48 drugs in the table above was 273.8 days. It should be noted that in many instances the failure to meet the 180-day statutory benchmark may have been justified and in such cases,” HHS wrote.

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