Untitled Document

FDA Reform

An Agency Meant to Protect Us Seems More Entranced by Profit & Progress than Public Good.

Left Field by Patricia Nell Warren

Once upon a time, Americans believed that their government was “of the people, by the people and for the people.” But these days, many of us have the creepy feeling that government is no longer on our side. Indeed, government often seems to come down on the side of corporations or institutions who are mainly interested in taking advantage of us in some way.

So far, in spite of Americans’ growing rage at our broken healthcare system, government has done little to fix it—or to come up with something better. Part of what’s “broken” about healthcare is that the federal agency entrusted with protecting us from abuses—the Food and Drug Administration—has let itself be co-opted (with a little help from Congress and the White House) by commercial interests that seem more interested in our money than our welfare. Indeed, there is a growing clamor for FDA reform.

History can show us how far the FDA drifted from its original purpose. In 1785, Congress passed our first food-safety law. Anybody who got caught selling “diseased, corrupted, contagious or unwholesome provisions, to the great nuisance of public health and peace” was to be punished by fines, imprisonment, or standing in the pillory. But creation of a real watchdog agency was slow. By 1862, the FDA was still just one lone chemist who eyeballed our food supply. Not till 1906, and passage of the Pure Food and Drug Act, was the FDA empowered to monitor drug marketing; after that came a cascade of more acts and expanded powers.

Today the FDA has swollen to nearly 10,000 employees and a budget that tops $1 billion. According to its own Web site, the agency “evaluates applications for new human drugs and biologics, complex medical devices, food and color additives, infant formulas and animal drugs. It also monitors the manufacture, import, transport, storage and sale of about $1 trillion worth of products annually at a cost to taxpayers of about $3 per person.”

This all sounds good on paper. The problem is, today’s FDA is the center of controversy and loss of public confidence in its integrity. There have been all too many noisy scandals about unsafe drugs that both a pharmaceutical company and the FDA allowed to be sold.

This year is a watershed year for the FDA. The 1992 Prescription Drug User Fee Act is up for renewal by Congress. PDUFA was passed on the heels of that nineties trend to create a fast track for AIDS drugs and other drugs. The FDA began accepting user fees from the pharma industry to process drugs. The result, according to the Alliance for Human Research Protection: “The re-prioritization of rapid approvals occurred at the expense of drug safety standards, and the consequences are documented by mounting drug-induced injuries, hospital emergency admissions, and preventable deaths.”

Yet chances are good that PDUFA will be renewed. The Center for Medical Consumers says, “The FDA is now financially dependent on revenues from the user fees paid by drug manufacturers who have a lot at stake in getting FDA approval…It is unlikely that a fiscally conservative Congress would agree to replace user fee income with a budget appropriation.”

FDA is not the only government body that fattens on fees. The trend is proliferating everywhere, right down to local levels. Fees amount to an “appropriation” that doesn’t have to be approved by Congress or a state legislature or city council. This, in turn, creates a situation where government will do more of whatever it has to do in order to get more fees.

Gone are the days when offenders against the 1785 act were punished by being put in the pillory, with their heads locked in that stout wooden structure so they couldn’t move. For a few hours, they could be pelted by rotten eggs and dead cats, maybe even kicked in the ankles a few times. Today the purveyors of “corrupted” drugs, whether they be researchers, corporate executives or government gate-keepers, usually just pay a fine if they happen to get caught.

These days, I have moments of irritation at bad government when I think that a pillory on Capitol Hill and a few purveyors in it might not be a bad idea. But I’ll settle for reform, and an FDA that we can trust with our lives.