The Drug Safety and Accountability Act, a bill filed today by Senator Michael Bennet (D-Colorado) is long overdue in protecting American citizens from unsafe drugs.
This past April, a Johnson & Johnson recall of more than 40 brands and 130 million bottles of children’s over-the-counter medications left worried parents here in Colorado and across the country scrambling to empty their medicine cabinets of the potentially harmful products. In this downward trend in patient safety, last year saw more than 1,700 drug recalls – four times more than in 2008 – that were mostly tied to manufacturing quality.
Why are Americans more at risk now?
Drugs – or their ingredients – made overseas, where quality standards may be lower, pose a serious threat. Three years ago, blood thinner (heparin) contaminated in China entered this country and led to the deaths of more than 100 Americans. In June of this year, drug makers recalled intravenous antibiotics made in India because of mold contamination.
Today, at least 80 percent of the active ingredients in U.S. drugs are made overseas. Second, the FDA, which is charged with ensuring the safety and efficacy of U.S. drugs, lacks the resources and authority needed to safeguard our drug supply in an increasingly global market. For example, while the FDA inspects U.S. factories on average every two to three years, a factory in China receives FDA oversight much less frequently.
These recent disturbing, and sometimes deadly, incidents serve as a wake up call that Americans are not adequately protected from the risks of unsafe drugs. The problem is twofold. First, many drug companies have shifted their manufacturing operations outside of the United States to developing countries such as China and India.
Fortunately, help is on the way: Bennet’s Drug Safety and Accountability Act would strengthen manufacturer quality standards and give the FDA the tools it needs to ensure our drugs are safe, no matter where they are made.
A Pew Prescription Project poll released Aug. 3, 2010, shows that most Americans are concerned about drug safety, particularly the safety of drugs manufactured overseas, and support increased regulation. Seventy percent of respondents have little or no confidence that drugs manufactured in China are free from contamination and safe for Americans; 54 percent of respondents expressed the same concern about drugs manufactured in India. Ninety-four percent of Americans favor giving the FDA recall authority for drugs, which it currently lacks. Currently, almost all drug recalls are voluntary.
The Bennet bill would hold the pharmaceutical industry to a higher standard by strengthening industry oversight of suppliers and contract manufacturers. To better regulate manufacturing, it would ensure the FDA has the accurate and up-to-date data on domestic and overseas manufacturing sites. (Current FDA databases are out of date and ineffective.) And it would provide the FDA with essential new authorities to protect the U.S. drug supply, including mandatory recall authority and the power to subpoena documents and witnesses.
Moreover, the bill would prevent FDA from relegating over-the-counter (OTC) drugs to a lower risk category simply because of their OTC status. FDA has traditionally focused supply-chain oversight on manufacturers of prescription drugs, but serious quality issues, such as those prompting the Johnson & Johnson recalls, have been identified at OTC plants in recent years.
Americans deserve the peace of mind that the drugs we take to improve our health and well being are safe and effective. We cannot wait for another heparin crisis with tragic consequences before we take action, and the Bennet bill is an important step forward. The Johnson & Johnson recall may have been the latest wake up call – let’s make sure it’s the last.
Lynn Parry, M.D. is chair for the Colorado Prescription Project. EDITOR’S NOTE: This is an online-only column and has not been edited.