Drug safety must be a priority with user fees

Seven in 10 prescriptions filled today in the United States are for generic drugs. Generic drugs also save consumers an average of $8 billion to $10 billion per year. One of the key characteristics of generic drugs’ initial and continuing success is the Food and Drug Administration’s assurance that they are identical to brand-name drugs in, among other things, quality, performance and safety. The safety of the drug you or your spouse or your child take is too often taken for granted — how that generic or brand-name drug ended up in your medicine cabinet is a question you probably don’t ask yourself. But maybe you should. 

The fact that, between 2001 and 2008, the number of generic and brand-name drug products manufactured outside of the United States has doubled, with nearly 40 percent of drugs taken domestically coming from overseas and with almost 80 percent of the active pharmaceutical ingredients that make these drugs effective also being produced overseas, shows that it is imperative that proper enforcement of quality standards be put in place across the globe for this to be a safe space for pharmaceuticals. Otherwise, our trust can be broken anywhere along the global supply chain: at an active ingredient manufacturing plant in China, a final drug-product facility in India or a packaging warehouse in Thailand.

If you assume the regulations are already in place for the FDA to monitor our drug-supply chain, you would be wrong. Current law has not kept pace with an increasingly globalized marketplace. Due to a lack of authority, the FDA does not have the knowledge of the number of generic-drug facilities in operation because it does not require registration, the FDA cannot refuse entry or seize counterfeited drugs at the border, the FDA cannot require manufacturers to document their supply chains or have in place a quality agreement and the FDA cannot mandate a recall of drugs known to be a danger to public health. And due to a lack of funding and personnel, as well as an antiquated law requiring biennial inspections for U.S. manufacturers but nothing for foreign facilities, the FDA inspects the manufacturing practices of domestic drug manufacturers every two years, but only inspects foreign drug manufacturers every nine years, if at all. This is frankly unacceptable.

What is clear to me is that the 1938 Federal Food, Drug and Cosmetic Act must be modernized to reflect the globalized nature of producing and manufacturing drugs. This will ensure that the FDA has proper oversight over drugs entering our country, and will provide a level playing field for our domestic drug manufacturers. The Generic Drug User Fee Act (GDUFA) takes a strong step in that direction by providing the FDA with resources to conduct comparable inspections of both domestic and foreign drug facilities. Parity in inspections will help the FDA ensure that all industry participants in the U.S. generic-drug supply are held to the same high standards using a risk-based approach. GDUFA will also ensure all contributors to generic drug products sold in the United States today are registering with the FDA. This will help the FDA track where drug products are coming from, and will help to reduce any disruptions in the pharmaceutical supply chain that can — and do — lead to drug shortages of critical medicines that Americans rely on. 

GDUFA is a step forward toward securing our drug supply chain, but there is more that we must do. Congress must take a serious look at how the FDA’s inability to oversee our drug supply is disadvantaging American business and possibly endangering the public health of our nation. GDUFA is an achievement that we must build on, and to be truly successful in our efforts to secure American jobs at home and strengthen consumer safety, Congress must address vulnerabilities in the oversight of our drug supply chain, and I call on my colleagues to work with me to do so. 

I have said this in the past, and I say it again: Drug safety is not a partisan issue. The authorization of the Generic Drug User Fee Act and the reauthorization of the Prescription Drug User Fee Act are wonderful opportunities to make significant drug-safety progress. Let’s show the American public that Congress can come together in a bipartisan, bicameral way to achieve a real solution to this pressing problem.

Dingell is a senior Democrat on the House Energy and Commerce subcommittee on Health.

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