Opinion

FDA Budget Cuts and Increased User Fees Are Bad for America

By Ken McEldowney
June 7, 2017 at 5:00 am ET

The first 100 days of life under President Donald Trump has been a tumultuous time. While policy proposals from his White House are generally light on details, consumer advocates can use the president’s budget proposal as a window into his priorities. And while the continuing resolution that passed last week funded the federal government through September at or near previous levels, President Trump’s call for “a good shutdown” in September reveals his ultimate agenda. His own plan, the grandiosely titled “America First: A budget blueprint to make America great again”, includes $54 billion dollars in cuts to a variety of government programs, many of would decimate key U.S. consumer protections.

With the president’s ill-advised tweets stealing thunder from the need for sound policy decisions, it’s easy to forget that consumer protections, and the agencies that enforce them, exist for a very good reason. For example, the official mission of the FDA is to protect “the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics and products that emit radiation.” Even in this day and age, when government seems to bear the blame for everything, protecting our safety and health remains a good use of taxpayer dollars.

The White House is proposing a major increase in FDA user fees, which are collected every time a new drug or medical device is submitted for a review. While increasing these fees might help offset costs, it’s unrealistic to think they can make up for total cuts.

The nearly-15,000 person FDA plays a regular and visible role in our lives, setting policy for review and labeling of foods and drugs in kitchen pantries and medicine cabinets across the country. Its mission is vital to keeping our food and prescription drug supply safe and secure.

The internet has generally made products of all kinds cheaper and more available to consumers, with widespread benefits. On the downside, it has provided a platform for bad actors to prey on unsuspecting customers seeking to stretch their ever-dwindling incomes.

The global market for dietary supplements was $82 billion as of 2013. Many of these supplements — containing untested ingredients — are sold directly to customers online. Surprisingly, these products can go into the market without any safety, purity or quality testing by the FDA. Margaret Hamburg, FDA commissioner from 2009 to 2015, echoed many when she observed that there is a widespread “concern about where these products are coming from and what’s in them.” Consumer Reports found that an estimated 23,000 people annually end up in the emergency room after taking supplements. To fulfill its agency mission, the FDA must be empowered and funded to oversee product integrity for dietary supplements.

The FDA, even at former funding levels, is stretched too thin enforcing laws currently on the books. Unapproved drug products to treat glaucoma and asthma, as well as cosmetic treatments such as illicit Botox, have been seized by FDA enforcement officials. However, the FDA is limited, by statute and funding, in monitoring the vast sea of questionable counterfeit drugs and dietary supplement products online.

Low penalties, combined with the already inadequate FDA budget, don’t incentivize the kind of prosecutions needed to stop of the flow of illicit products. According to a recent Washington Legal Foundation brief, “A number of statutory gaps in the penalty provisions of the Food, Drug and Cosmetic Act (FDCA) pose a risk to American consumers including unequal treatment of counterfeiting and diversion, as well as differing penalties for certain types of diversion.” Combined with chronic underfunding of the agency tasked with enforcement, these statutory gaps hinder regulators and prosecutors from stopping the bad actors.

It’s likely that the user fees proposed by the Trump budget would go to fund the expedited approval of new drugs, which while commendable if done safely, would jeopardize the agency’s other duties. President Trump needs to understand the true impact of his proposed budget cuts. If he doesn’t, Congress must step up and fill the leadership void.

 

Ken McEldowney is executive director of Consumer Action, a nonprofit organization working for social change since 1971.

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