Cost of Compliance – FDA’s New Enforcement Discretion

March 31, 2011

By Roger C. Thies

FDA announced on March 30, 2011 that  it “does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products.”   This announcement is contrary to FDA’s long-standing policy to not permit pharmacy compounding of drugs that are commercially available and approved by FDA.  See FDA, Compliance Policy Guide 460.200 – Pharmacy Compounding.

This change in policy was apparently necessitated by FDA’s approval of Makena® (hydroxyprogesterone caproate) for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth coupled with public complaints about the cost of Makena®.

It is no secret that regulatory compliance costs industry and consumers money.  Cost is not the issue when there is a request for just one more study that delays approval or the Phase 4 commitment that FDA wants to supplement its database.  Companies are routinely faced with increased costs for more validation of manufacturing processes or more thorough investigations.  A response that compliance just costs too much does not preclude regulatory action such as consent decrees, delays in approval of new products or refusal to grant export certificates.  FDA has forced “old” unapproved drugs from the market once the same product(s) are approved.  Invariably, the monopoly provided by FDA to the company with the approved new drug has led to higher drug prices to the consumer and to other payors.  All of these added costs are justified as necessary to ensure the safety and efficacy of FDA regulated products.

Now FDA has deviated from its customary posture.  In its announcement FDA states that “greater assurance of safety is provided by an approved product.”   If so, why did FDA decide to change its enforcement priorities?  Was it product cost?   Political pressure?  It appears so.  There is a lesson here.