The Trump ef­fect: PwC re­port says the FDA has slammed the brakes on sig­nif­i­cant new drug reg­u­la­tions

Don­ald Trump launched his pres­i­den­cy breath­ing fire on fed­er­al reg­u­la­tions. And the top of­fi­cials at the FDA heard that call loud and clear.

Scott Got­tlieb

A new re­port out from Price­wa­ter­house­C­oop­ers shows that the agency reined in its is­suance of new fed­er­al reg­u­la­tions to a 20-year low in 2017, as the Scott Got­tlieb stepped up to the helm as com­mis­sion­er.

In­stead, the agency has shift­ed to new guid­ances in pref­er­ence to hard­line reg­u­la­tions, says PwC. And that will like­ly come as a wel­come em­pha­sis in the bio­phar­ma in­dus­try, where we’ve seen the FDA re­peat­ed­ly demon­strate its will­ing­ness to re­lax old stan­dards to ac­cel­er­ate new drug de­vel­op­ment.

Over the 4-year run of the Oba­ma ad­min­is­tra­tion, says the re­port, the agency is­sued 132 “eco­nom­i­cal­ly sig­nif­i­cant” reg­u­la­tions for the in­dus­try as a whole — an av­er­age of 33 per year. Un­der Trump and Got­tlieb, that dropped to a low of just 6.

And while the num­ber of new drug ap­provals has soared to a record high, with 53 new ap­provals — a com­bi­na­tion of bi­o­log­ics and new chem­i­cal en­ti­ties — PwC sees the FDA large­ly stay­ing the course on in­dus­try over­sight, in­spec­tions and en­force­ment.

For the phar­ma­ceu­ti­cal in­dus­try, the FDA un­der Got­tlieb’s tenure has been pre­dictable, sta­ble and con­sis­tent, al­low­ing com­pa­nies to con­tin­ue in­vest­ments in­to drug re­search and de­vel­op­ment and ex­ist­ing com­pli­ance pro­grams with­out fear of a ma­jor change in reg­u­la­to­ry ap­proach. While Got­tlieb’s reg­u­la­to­ry phi­los­o­phy is per­haps more in­dus­try-friend­ly than past FDA com­mis­sion­ers, the agency’s broad­er ap­proach from en­force­ment to ap­provals has not been an abrupt de­par­ture from ex­ist­ing trends and norms.

A few oth­er high­lights:

  • Or­phan drug ap­provals rock­et­ed to a new high, with 64 new ap­provals in 2017, un­der­scor­ing a trend dri­ven by small­er clin­i­cal tri­als and steep prices for new roll­outs re­strict­ed to tiny pa­tient pop­u­la­tions.
  • Da­ta in­tegri­ty re­mains a key con­cern. And reg­u­la­tors re­main vig­i­lant about is­su­ing qual­i­ty re­lat­ed warn­ing let­ters.

Will the agency’s move to brake new reg­u­la­tions last through 2018?

Per­haps not, says the PwC re­port. A look at his­tor­i­cal trends show a dra­mat­ic in­crease in the sec­ond year of the George W Bush ad­min­is­tra­tion, with a more mod­est 15.4% in­crease in the sec­ond year of the Oba­ma ad­min­is­tra­tion. And their an­a­lysts flagged a list of sig­nif­i­cant new regs now un­der de­vel­op­ment at the FDA that could have a big im­pact on bio­phar­ma com­pa­nies.

As we re­port­ed re­cent­ly, Scott Got­tlieb and the FDA are held in high re­gard by drug de­vel­op­ers. And the PwC group found that there’s still a big push on for fur­ther eas­ing FDA stan­dards for ap­proval, as well as clin­i­cal and pre­clin­i­cal reg­u­la­tions.


Im­age: Pres­i­dent Don­ald Trump speaks with re­porters in No­vem­ber, 2017. Shut­ter­stock. Charts: PWC

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Jackie Fouse, Agios CEO

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George Yancopoulos (L) and Len Schleifer (Regeneron)

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