Committee raises hackles with FDA picture

Drug Store News, June 24, 1991 by Ken Rankin

Committee raises hackles with FDA picture

A little more than a year ago, the Food and Drug Administration hit rock bottom.

Repeated funding cuts by Administration penny pinchers had eroded the agency's enforcement muscle, while the deepening generic drug approval scandals sapped FDA's will and destroyed staff morale.

Health and Human Services Secretary Louis Sullivan appointed ex-FDA Commissioner Charles Edwards to head a blue-ribbon advisory panel to study the agency's problems and recommend solutions.

No big deal. Here in Washington they form special advisory panels every ten minutes or so. Bureaucrats and politicians love these study groups because they're a way to delay painful but inevitable change.

In the case of the Edwards Committee, however, the Washington bigwigs got more than they bargained for. Indeed, ears are burning all over town.

The picture of FDA painted by the study group is of an agency literally stretched to the breaking point - a regulatory body that is "not prepared to cope" with the responsibilities assigned to it.

There's more than enough blame to spread around, according to the report.

The administration deserves much of it for lobotomizing FDA's rulemaking authority and submerging the agency into a bureaucratic Bermuda Triangle within the Public Health Service.

Congress deserves its share, and then some, for heaping new responsibilities on FDA without appropriating funds to properly carry out those duties.

Militant special interest groups ranging from true-believers in the animal rights movement to shrill-voiced AIDS activists have made an almost impossible job even more difficult for FDA.

State legislators from Maine to Maui have tried to undercut FDA's authority over foods and drugs by designing their own conflicting regulatory standards.

Even us in the (gasp!) news media contributed to the agency's internal paranoia by subjecting day-to-day decisions by FDA officials to intense scrutiny.

In short, it's a wonderful report packed with conclusions and recommendations certain to infuriate just about every possible side.

The solutions recommended by the committee, however, may be even more controversial.

HHS Secretary Sullivan - the guy who called for the study in the first place - is less than thrilled with the panel's proposal to slash his Department's authority over FDA.

House Energy and Commerce Committee Chairman John Dingell (D-MI) - the person who stirred up the generic drug hornets nest in the first place - is livid over criticism about Congressional micro-managing of the agency.

The army of self-appointed "consumer advocates" and special interest radicals who roast FDA at every opportunity are furious that some of the heat has been turned in their direction.

The wine and quiche crowd in Sacramento is having fits over suggestions that FDA should veto their plans to concoct their own politically correct labeling requirements for drugs and cosmetics.

I love it!