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FDA Regulation Cutting Will Impact Drug Approvals Too

FDA Regulation Cutting Will Impact Drug Approvals Too | Pharma Industry Regulation |

During the campaign, candidate Donald Trump made several statements referring to the fact that he would be cutting regulation in this country by 70-80 percent. Since the election, that sentiment has been repeatedly affirmed.


Now in office, this week he signed an Executive Order that would require that federal agencies seeking to implement a new regulation must first do away with two (read “Imagine a World Without FDA Guidelines. I Wonder If You Can”; The Executive Order also set an annual financial cap on the cost of new regulation and that stated for the rest of 2017, the cost of new regulation must be offset by the undoing of old regulations.


How might that impact FDA? Especially in the wake of the passage of the 21st Century Cures Act, there will be a number of regulations that will have to be devised and go into effect and the agency is still constructing the regulatory pathway for biosimilars. But the executive order issued by the Administration exempts rules and regulations that are being mandated by legislation.


Also this week in a meeting with PhRMA, Trump specifically indicated not only that FDA was included in the mix for regulation-cutting, but also that the approval process would be streamlined to shave significant amounts of time from the approval process.


The drive for fewer regulations has a potential for impact on a number of fronts. At least one of the persons being considered for FDA commissioner has stated that drugs should be approved once safety is established and that efficacy would be determined in the market place (read “Why Donald Trump's Putative FDA Pick Should Scare Pharma & Patients”; In addition, it could mean that drugs that are under study have greater access for those patients who wish to try unapproved drugs, or “right to try” policies. Fewer regulations could also take the form of minimizing FDA’s role in conducting inspections of manufacturing facilities. Finally, when it comes to “streamlining the approval process” it could have a direct impact on the way drugs are currently evaluated for approval, specifically reform of the advisory committee structure and function.

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