While a great deal has been written about the negative effects of regulation
on innovation in all sectors, and surveys have been conducted regarding the stifling effects of regulation on medical innovation
, there is no independent analysis and scoring of policies, rules, guidance documents, and proposals relative to their likely impact on medical innovation.
During the rule-making process for regulations that are economically significant (having a likely impact of at least $100MM), a Regulatory Impact Analysis (“RIA”) is required, which includes evaluations stipulated by Executive Orders 12866 and 13563. But, no such analysis exists to evaluate rules solely relative to their impact on the advancement of medical innovation. Moreover, the RIA is not mandated for guidance documents, which are the methods by which the FDA publishes detailed interpretations of its rules, truly where the rubber meets the road.
Medical innovation is too important to be neglected or left to regulators to weigh. Our understanding of fundamental biology is progressing at a lightning pace and providing tremendous medical discoveries and insights. Patients are demanding more immediate access to cutting edge therapies as evidenced by the Right to Try Law movement. Investors have increased the pace at which they have been allocating capital to the sector broadly. However, over-regulation and the inconsistent application of laws and rules continues to handicap the timely development and approval of new medicines and devices.
Nothing transformative is being done to address the problem principally because it is hard to do. For government agencies like the FDA, it is easier to propose rules and guidance documents with great sounding titles in order to deflect criticism of inadequate performance. For elected officials who need to show activity within their term periods, it is easier to mollify constituents with proposals and laws that give some acknowledgement of their pain, but accomplish little. For drug developers, it is easier to target diseases for which the greatest regulatory incentives exist because this provides the quickest way to maximize shareholder value.
Seemingly, no one wants to perform the hard work of analyzing the implications of the system of laws, rules, guidance documents, policies, and resultant modus operandi relative to their collective impact on medical innovation.
We do. And, it is critically important to patients and society that we perform this difficult work.