FDA has more work, less money
The U.S. Food and Drug Administration, which regulates products that account for 25 cents of every dollar spent by consumers, is always embroiled in controversy.
Some say it approves new drugs too quickly, while others say its delays cost lives. Some say our food supply is relatively safe, while others point to unsafe foods that have entered the market. Some say the FDA should take more aggressive enforcement actions, while others say it should rely on voluntary compliance.
But there’s one thing that virtually everyone agrees on: The FDA needs more money to do its job properly. This consensus includes patient organizations, consumer and research groups, the professional community, and all the industries the agency regulates.
Consider this anecdote from a report presented to the FDA by its own science committee: The agency had to bring in retired computer experts to repair its servers, because the equipment was so out of date that younger repairmen did not know how to fix it.
Or consider that the FDA inspects less than 1 percent of the food imported into the country each year, and it sometimes goes years without inspecting facilities where prescription drugs and medical devices are made.
The agency has the same number of employees it had in 2004, though Congress has given it much more responsibility since then.
Added duties
Consider these points:
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.
Congress assigned the FDA to regulate tobacco products, and it can charge the tobacco companies fees. But the fees cannot cover the time needed to oversee the new regulatory activities at the most senior levels of the agency.
If a health-care reform bill does pass, the FDA is likely to have still more responsibility, without more funding.
Budget experts estimate that the FDA needs an increase of $120 million next year just to maintain its present staffing and activities. Undoing the consequences of years of budgetary neglect will require several hundred million dollars more the following year. And the significant new authority that Congress is in the process of giving the FDA will require $400 million or more in new funding over the next three to four years.
No relief in sight
Every year at this time, the president sends a budget to Capitol Hill. All indications are that the one being prepared will provide no increases for the FDA.
There may be debate about what role the federal government should play in education, transportation, or health care. But there is little debate over whether the federal government must play a role in assuring that our food is safe, and that our drugs and medical devices are safe and effective. 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 we as consumers had to fend for ourselves in the supermarkets or restaurants, or if we did not know that the prescription drugs we get at the pharmacy or hospital had been tested thoroughly.
National resources are scarce, and priorities are hard to set. Our leaders face delicate balances. But let’s hope that the essential services the FDA provides get the attention they deserve. We cannot afford to take the risk of continuing to deny the agency the money it needs to protect us.
