Major Deregulation? FDA Withdraws Several Rules and Regulations Related to Medical Products

  • June 14, 2018

Since those comments in January 2017, the United States Food and Drug Administration (FDA) has withdrawn the most rulemakings of any Department of Health and Human Services (HHS) Agency, though only a handful are related to medical products (the others are tobacco related) and it is unclear how the withdrawal of these proposals and regulations in 2017 will impact patient safety or industry burdens.

A new report from the nonprofit Public Citizen released at the end of November 2017 released this week, discusses not only the regulations withdrawn in 2017 but how this administration “has done a lot to slow down or stop ongoing rulemakings.”

For instance, according to HHS’ regulatory agenda published in August 2017, the finalization of a rule on drug labels, “to reflect certain types of newly acquired information in advance of FDA’s review of such changes,” has been pushed back indefinitely, the finalization of a rule related to accepting certain clinical data to bring new medical devices to market has been delayed to next month and the finalization of an FDA rule on post-marketing safety requirements has been pushed back to October 2018.

And since Trump took office, withdrawals of rulemakings and regulations related to medical products occurred in April and June of 2017 and include one on patient labeling, “to help patients use their prescription drug products safely and effectively”; another on clinical trials that would have updated the Investigational New Drug (IND) application regulations to “better protect the rights, safety, and welfare of subjects and help ensure the integrity of clinical trial data”; a third on updating and harmonizing current good manufacturing practice (cGMP) regulations for finished pharmaceuticals; a fourth to revise regulations for cGMP with regard to components used in manufacturing finished pharmaceuticals; and a fifth that would have regulated the format and content of reports intended to demonstrate substantial equivalence.

However, on the topic of whether 75% to 80% of FDA regulations will be cut moving forward, a White House spokesman referred Focus (RAPS) to FDA, which referred to a blog post from Anna Abram, FDA’s Deputy Commissioner, on considerations the Agency takes in determining which rulemakings to withdraw.  The blog post highlights comments sought by FDA on which rulemakings could be modified, repealed or replaced, to reduce the burden on industry while allowing FDA to continue its public health mission, though in early November 2017, FDA Commissioner Scott Gottlieb said a lot of FDA’s Regulations are de-regulatory in nature so they do not need to be cut.

REFERENCE:  RAPS; 29 NOV 2017; Zachary Brennan

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