An expedient drug-approval process may have led to an increase in warnings, recalls, and reports of side effects in prescription medication, a recent study suggests. The study, published in the August issue of Health Affairs, examined the records of drugs approved before and after the passage of the Prescription User Drug Fee Act (PUDFA), a 1992 law that sped up the drug approval process using fees collected from pharmaceutical companies.
Researchers found that the rate of warning or withdrawal increased by five percentage points among medications approved after 1992, when PUDFA went into effect. The findings have prompted calls for the federal government to strengthen the drug approval process.
“New drugs have a one-in-three chance of acquiring a new black-box warning or being withdrawn for safety reasons within twenty-five years of approval,” researchers told Medscape Medical News. “We believe that the ultimate solution is stronger U.S. drug approval standards. In the interim, with the rare exception of truly breakthrough therapies, doctors should preferentially prescribe drugs that have been on the market longer and hence have a more established track record of safety.”
Many public health experts had cause for worry long before the release of this week’s study, primarily because of the Food and Drug Administration (FDA)’s reliance on agency drug review fees doled out by pharmaceutical companies. A 2002 Government Accountability Office report found that the 1992 legislation often increased the workload for the handful of prescription drug reviewers at the FDA. In 2006, a $1.8 million study from the Institute of Medicine cited major deficiencies in the FDA’s drug approval system, and ultimately recommended an increase of regulatory powers, funding, and autonomy for the federal agency. Such recommendations may have prevented a 300 percent increase in drug recalls between 2008 and 2009 due to what officials considered the subpar quality of raw materials, faulty labeling, and contamination.
Lax FDA regulations have also been criticized for undermining public health in other areas. The dearth of employees at the federal agency available to check food labels has led to an increase of misleading food labels on the market — including that of so-called whole wheat products that in fact contain lots of flour. In the early 2000s, the FDA allowed nicotine-containing beverages to reappear on the market as dietary supplements. And earlier this year, more than two dozen state attorneys generals criticized the federal agency for what they considered weak regulation of e-cigarettes, a product they said would expose an entire generation to dangerous chemicals and act as a gateway to traditional tobacco products.
While the FDA has seen an increase in its regulatory power through changes in the drug review process and the passage of the Food Safety Modernization Act in 2011, a bevy of unapproved drugs still flood the market, including codeine sulfate tablets and balanced salt solution products. Drug companies market these products — many of which come without labels that outline its status as an unapproved drug — in a way that leads people to assume that they’re generic, especially those that have been on the market for years.