Former FDAer (1979-93) Henry Miller, now a Hoover Institution fellow, says FDA would be a good place for the Obama administration to demonstrate it is serious about having a government that operates “in a sensible, cost-effective way.” Writing online for The American magazine, Miller lists specific FDA programs that he considers ill-conceived or counterproductive.

First, he suggests dropping an initiative announced in 2007 to comprehensively assess some new drugs’ safety within 18 months of their introduction and to issue a performance report card. “Although this may sound sensible,” Miller writes, “it is inconsistent with data showing that, in fact, newer drugs confer an advantage over older ones in reducing mortality.” He recommends eliminating the initiative or restricting it to only those drugs that are very widely prescribed and whose clinical trials raised a possible safety concern.

Next, he suggests that the Drug Watch program has more to do with public relations than with public health because it releases information before FDA has fully determined its significance. Miller says the program’s only possible value is to trial lawyers trolling for business.

He also targets the “massive, largely superfluous bureaucracies that serve the commissioner and a horde of deputy commissioners, associate commissioners, and assistant commissioners,” so that resources can be freed for essential programs.

Miller complains that a recent memorandum of agreement on relationships between the Office of New Drugs and safety reviewers will slow drug development and increase its costs. Giving safety reviewers equal status with medical reviewers in dealing with safety issues is a problem, he says, because people in the safety area are “focused so narrowly on safety that they ignore the fact that because all drugs have side-effects, safety cannot be evaluated in a vacuum. Instead, it must be part of a risk-benefit judgment.” He recommends that the safety officers be returned to an advisory role.

Finally, Miller challenges a recent FDA announcement that every new genetic construction in an animal that employs gene-splicing technology must undergo evaluation under the same procedures and regulations as those for drugs used to treat animal diseases. He says a more appropriate model for gene-spliced animals is FDA’s oversight of traditional foods and food additives of natural mutants and of livestock clones that FDA has decided are safe to eat. “This approach would ensure food safety but would be far less labor and time intensive for FDA personnel, and it would be far less anti-innovative and punitive to an emerging industry,” he writes.