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# Trump to Lower FDA Approval Standards: ex-Pfizer Exec LaMattina
- URL: https://www.fdaweb.com/trump-to-lower-fda-approval-standards-ex-pfizer-exec-lamattina/
- Published: 2016-11-14T12:00:00.000Z
- Updated: 2026-09-14T21:47:24.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137326

FDA may be forced to lower its approval standards under the Trump administration, according to former Pfizer Global Research and Development president and *Forbes* contributor **John LaMattina**. Writing in a recent [article](http://www.forbes.com/sites/johnlamattina/2016/11/14/donald-trump-and-the-fda/?ref=fdaweb.com#5f3fff6f50c0), LaMattina takes a cue from in president-elect **Donald Trump**’s recent release of his [First 100 Days Action Plan](http://www.npr.org/2016/11/10/501597652/fact-check-donald-trumps-first-100-days-action-plan?ref=fdaweb.com) to read the tea leaves of what’s in store for the agency — reforms will include cutting the red tape at FDA because there are over 4,000 drugs awaiting approval, and “we especially want to speed the approval of life-saving medications.” 

According to LaMattina, the approval bar will be lowered for generic drugs. The backlog at FDA is pretty large, he notes, and some companies have used these delays in generic competition to raise prices on their products. For orphan products, the recent controversial approval decision for Sarepta’s Duchenne drug eteplirsen ([see story](https://www.fdaweb.com/documents-show-how-contentious-woodcocks-exondys-decision-was/)) may be an opening to allowing other products on the market with less evidence.

LaMattina also believes that restrictions will be eased on the off-label use of already approved products. “While FDA final approval will be ultimately required, the publication of clinical trials showing the benefit of the drug in a new indication will be sufficient to allow companies to discuss the new use of such a drug with physicians and other health care professionals,” he says. “There will be push back against such changes not just from regulators but also from payers who normally want absolute proof of a drug’s efficacy before providing reimbursement. The FDA will also justifiably raise concerns about exposing the American people to unnecessary risks.”

***FDA Webview* editor Jim Dickinson comments:**  
I respectfully disagree with Mr. LaMattina. The view often looks different from the other side of the regulatory fence. My experience inside FDA (although not as an employee) leads me to believe that the agency’s ingrained internal culture won’t allow its international “gold standard” for drug approvals to be lowered for any reason. This notwithstanding the aberration of CDER director **Janet Woodcock**’s staff-demoralizing approval of Sarepta’s eteplirsen for unscientific compassionate reasons, extension of that precedent would likely cause a revolt, aided from the outside by Capitol Hill defenders and citizen watchdog organizations, to say nothing of the news media and the alumni of ex-FDAers.

More to the point, perhaps, across the federal bureaucracy, the permanent establishment below the political level in agencies like FDA, and certainly FDA itself, have ways of “capturing” those sent to tame them and deflecting their intentions. That’s what **Barack Obama** found when the bureaucracy let him know that it didn’t want him to have “the most transparent government in history” as he promised the electorate when running for office. There’s a long trail of other campaign promises by other politicians over the years that came to grief the same way.

Notwithstanding surface impressions projected by the media, real, boots-on-ground power in Washington is exerted deep in the bowels of the permanent bureaucracy where daily orders from the political hierarchy seldom reach. At FDA, that power is felt in routine daily “by the book” bureaucratic interpretations of regulations and long-established standards and practices that are largely impervious to White House comings and goings.

That permanent fact of life is largely why FDA’s regulated industries try so hard to work within the system itself, rather than to seek political relief for their frustrations (although that is sometimes tried as a last resort — always without memorable result).