While the health care debate is distracting most Americans about who is going to get insurance and what conditions are going to be covered, one extremely important health agency—the Food and Drug Administration (FDA)—is receiving a little less attention. Why should this concern you?
According to a recent article in The Regulation Policy Market Access Report (RPM), the public should be concerned because the FDA is invoking legal doctrines that “if accepted by courts will shield FDA legal determinations from scrutiny for at least substantial periods of time,” according to attorney Arnold Friede.
His article describes how FDA guidance, both draft and final, “has replaced rulemaking as the primary mode for the agency to communicate its official position on many matters.” As a result, he asserts that any guidance from the agency becomes “the functional equivalent of a rule or regulation.” To highlight such changes, Mr. Friede discusses the Teva Case.
The Teva Case
Teva Pharmaceuticals USA Inc. v. Sebelius, involved a case of eligibility for a first applicant for a 180-day generic drug exclusivity. In deciding the case, “Judge Rosemary M. Collyer of the U.S. District Court for the District of Columbia squarely addressed and rejected many procedural obstacles, analogous to those advanced by FDA in the BBK case, interposed by the agency in an effort to avoid judicial review.”
In explaining this decision, Mr. Friede noted that since the FDA had not provided a “definitive answer” on the agency’s view regarding this issue, Judge Collyer stepped to “decisively reject a litany of procedural objections advanced by FDA in an effort to evade review on the merits.”
In fact, Judge Collyer held that “FDA’s earlier determination on two prior occasions involving different generic drugs of the precise statutory interpretation question in Teva effectively amounted to a “rule” that constituted “final agency action” for purposes of APA review.” In other words, since FDA had already made decisions on similar issues, their guidance from those prior cases essentially became an agency law.
Although FDA’s position was ultimately upheld, Mr. Friede wondered why the agency “went to such great lengths to avoid judicial review in the first place.” He noted that in a new era of American government, which calls for transparency, continuing these guidance practices that are not reviewable by courts is an “unwise and unsound approach.” He asserted that because the “FDA is not above the law,” the agency should welcome early and active judicial review as a way of progressing the agency’s public health mandate.”