No New FDA Regulations Means Keeping the Status Quo
​[Posted on: Thursday, February 02, 2017]

FDA will not be able to make any new rules due to President Trump’s executive order (EO) signed this Monday. The EO requires that before creating a new rule, the Agency must identify two existing rules that can be scrapped, hence the name “Two-For-One Order (ToFOO)”. Additionally, the cost for implementing the new rule must be equal or less than the cost of implementing the rules being scrapped thereby assuring a net cost change of $0.  This Order all but guarantees that FDA cannot create new rules in the near future. There are speculations as to how this impacts FDA’s finalization of several draft rules and guidance documents that were coming up for final versions. ToFOO is based on the assumption that all regulations are bad and need to be reduced. President Trump has repeatedly criticized “over-regulation” and hence vowed to cut regulatory burden on all aspects of governance. But most government agencies make new rules to implement the laws passed by the Congress. So, compliance with ToFOO in effect means that the Agencies will not be able to implement new laws. For example, how would FDA implement the recently passed 21st Century Cures Act without creating new regulations? Also due to cost element of rules being scrapped, the Agency cannot scrap old rules that are dated and no longer in effect or already due to sun-setting since the cost component is those is very low. It also adds to the work on FDA personnel to justify new regulations while also justifying older ones that need to go. The EO does exempt creation of new regulations if required by law, so technically new laws such as the 21st Century Cures Act should be exempt. Similarly, any new regulations created to implement new laws passed by the Congress should be exempt. But it clearly affects regulations that clarify or formalize previous positions. It also makes it practically impossible to amend the rules or add new provisions. For example, new rules for genetic diagnostic tests are now practically dead, so are the new rules supposedly being written for regulations of HCT/Ps. Finalization of the proposed rules for e-cigarettes and tobacco products should be become difficult for the FDA. Guidance documents are not binding regulations so some have speculated that FDA may decide to implement new policies via Guidance documents. However, lacking a clear regulation to back a given guidance document open the gate to legal challenges to the said guidance. There is a lot of confusion and for now all government agencies have suspended rule making till the OMB provide guidance on how to comply with ToFOO. Complaints about over-regulation are not without merit. FDA has been accused of bending or extending the rules despite public opposition. But FDA has also done an excellent job of protecting the US public from risky, non-working and poor-quality products. And most FDA reviewers have the power to make decisions without feeling the political pressure. So FDA will likely not change its review practices much. FDA still can enforce the laws on the books. And that’s a good thing. Industry like regulations, even when it uses them to justify cost and hurdles. If you were expecting major changes in FDA regulations, hold your horses.