Regulation Cutting Impact on FDA and AdComms

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.  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. 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.

A few days prior to his departure from FDA, Commissioner Robert Califf authored a posting on FDA’s blog (FDA Voice) entitled “FDA Advisory Committees: Independent, Informed, Essential and Evolving“- a title that tried to say it all – in which he outlined his thinking about the role of advisory committees. While the posting begins with a recognition that there is a common concern among medical leaders that the advisory committee system function be improved, the aspect that is discussed at length is process of evaluating advisers to serve and minimizing potential conflicts of interest.

But the advisory committee system has other issues, some of which are cumbersome. For starters, it is huge – just for human drugs alone there are 17 committees, each comprised of 10-15 people. Meeting logistics are involved, particularly if there is a joint meeting. The identifying, vetting and scheduling are enormous.

Then there is the burden of proof. A drug sponsor will have to compile an enormous amount of data and then have a very short amount of time to present it during a proceeding that may seem a combination of a scientific meeting and adversarial proceeding, examining both the safety and the efficacy of a compound. This may seem like a negative, but in fact (having witnessed scores of these meetings) they are very thorough which is something you the patient really want if you are staking your life on taking a medicine that is going to cure you of a serious illness or manage a chronic one. You want medicines held to a higher standard than supplements.

Needless to say, there are a good number of regulations associated with the delivery of a new medicine. The two-for-one rule is a very simple approach to a complex issue. Similarly cutting down on the scrutiny a drug candidate receives in order to get it to market faster may also seem like a simple approach to a complex issue. In both cases, in the end the outcome may not be what you were aiming for.

Ultimately the shape of advisory committees – and the faster speed of drug approvals – will not be determined for some time to come.  The choice of an FDA commissioner will likely shed a good deal of light on the direction, if not the timing. In the meantime, we are left to ponder three important questions.  First – if we were going to set aside 80 percent of FDA’s regulations – what would they be and where is the low hanging fruit? Second – is the means to getting rid of these regulations a sudden process, or the more gradual attrition by means of the two-for-one rule? And last, if we are not going to approve drugs by the system we have, what would a better system look like?

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