FDA has critical budget shortfall

By Wayne Pines

The U.S. Food and Drug Administration, which regulates products that account for 25 cents of every dollar spent by a consumer, always is engaged in controversy.

There’s one thing that everyone agrees on, though, and that is the FDA is underfunded and needs more money to do its job properly. This is a consensus held by patient organizations, consumer and research groups, the professional community and all the industries regulated by the FDA.

Consider this anecdote from a report presented to the FDA by its own science committee: The FDA had to bring back retired computer experts to repair its servers because they were so old and out of date, the younger repairmen did not know how to fix them.

Or consider that the FDA inspects less than 1 percent of the food that is imported into the United States each year, and sometimes goes for many years without inspecting facilities where prescription drugs and medical devices are made.

The FDA has as many employees as it had in 2004, but since then Congress has given it much more responsibility.

● For example, the FDA has been given new responsibility to establish more modern systems to gather and evaluate adverse drug reactions, but there is no added money to do so.

● The FDA was assigned by Congress to regulate tobacco products, and can charge fees to the tobacco manufacturers, but the fees can’t cover the time needed to oversee the activities at the most senior levels of the agency.

● And if a health care reform bill passes, the FDA is likely to have, without added funds, still more responsibility to regulate, for example, generic versions of biotech drug products.

Budget experts estimate that the FDA needs an increase of $120 million next year just to maintain present staffing and activities. Undoing the consequences of years of budgetary neglect will require several hundred million dollars more next year. And Congress is in the process of giving the FDA significant new authority that will require $400 million or more in new funding over the next three to four years.

Why should anyone care?

Easy. There may be debate about what role the federal government should play in education, or in transportation, or even in assuring health insurance to all Americans. But there really is no debate, and hasn’t been for some time, that the federal government must play a role in assuring that our foods are safe, and that our drugs and medical devices are safe and actually will do what they are supposed to do. We all take for granted the safety and quality of our food and medical products, and it remains newsworthy when there is a safety scare.

This assurance comes from the activities of the FDA, which sets and enforces standards for food and drug quality, and which approves new drugs and medical devices before they can be marketed. Imagine if the FDA did not exist, or could not do its job properly, and we as consumers had to fend for ourselves in the supermarket or restaurants. In some countries, where regulation and sanitation are deficient, that’s how people must live.

Or imagine if we did not know that the prescription drugs we get at the pharmacy or hospital have been tested thoroughly and approved by the FDA. That would undermine our confidence in the entire medical system and affect each of us adversely.

Let us hope that the essential services the FDA provides — protection of our food and medical products supply — gets the priority attention they merit. We cannot afford to take the risk of continuing to deny the FDA the money it needs to protect us.

Wayne Pines, a former associate commissioner of the FDA, is president of the Alliance for a Stronger FDA.