In his address to Congress last night, a speech widely praised for its gentler tone than much of his recent public rhetoric, President Donald Trump saved some of his few broadsides for the FDA.

Trump wove into his address the story of 20-year-old Megan Crowley, a Notre Dame sophomore who was among guests invited to sit with First Lady Melania Trump for the speech. Crowley’s life was saved through a Pompe disease treatment developed by Novazyme Pharmaceuticals, the drug developer founded by her father John F. Crowley, now chairman and CEO of Amicus Therapeutics.

Novazyme was acquired in 2001 for $137.5 million by Genzyme, which in 2011 was bought by Sanofi for $20.1 billion.

“Our slow and burdensome approval process at the Food and Drug Administration keeps too many advances, like the one that saved Megan’s life, from reaching those in need,” Trump said. “If we slash the restraints, not just at the FDA, but across our government, then we will be blessed with far more miracles like Megan.

The FDA is now led by an acting commissioner, Stephen Ostroff, M.D., pending U.S. Senate confirmation of a permanent commissioner. Trump at deadline has yet to nominate a permanent successor to Robert M. Califf, M.D., who left office the day Trump was sworn in.

Trump’s call for a speedier drug approval process echoes the comments of several CEOs who discussed the challenges and opportunities facing the biopharma industry in recent interviews with GEN.

“We are looking for a more streamlined process while, at the same time, thinking about the socioeconomic incentives that can be put in place, especially to help small companies as we move forward in trying to take early-stage products and get them to the point where they can get to later clinical development with the FDA,” Pulmatrix CEO Robert Clarke, Ph.D., said late last year.

Agreeing with that sentiment was John Manzello, president of Abzena US, who cited the European Medicines Agency regulatory framework as one that enabled faster reviews yet emphasized product safety: “While wholesale change of the U.S. policies won’t be immediate, an effort to examine a streamlined approach for the U.S. regulatory process would be most welcomed in 2017.”

Trump also urged Congress during his address to join him and “work to bring down the artificially high price of drugs, and bring them down immediately.”