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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Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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[via AP Images]

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Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

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Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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Tower Bridge in London [Shutterstock]

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