Senate bill would bolster drug safety requirements

Ken Johnson, a senior vice president of the Pharmaceutical Research and Manufacturers of America (PhRMA), the lobbyist giant for branded drugs, said the group is still examining the Bennet bill, but implied that stronger safeguards are unnecessary.

“Brand-name pharmaceutical companies make tremendous investments in quality control systems and take extensive measures to help protect patient safety and to help prevent adulterated ingredients from entering into America’s prescription drug supply,” Johnson said in a statement. “The U.S. regulatory system for prescription drugs is the toughest and safest in the world.”

Bennet’s proposal would update FDA data systems to track all global manufacturers feeding America’s drug supply; force companies to document each contributor to their products; grant FDA subpoena authority when conducting investigations; and empower FDA officials to recall drugs when safety issues arise — a power the agency currently has over medical device makers, but not the pharmaceutical industry.

Supporters of the proposal are armed with a slew of statistics backing their case. Last year, for instance, the country saw a record 1,742 drug recalls, they note — a 400 percent jump over 2008. More than 100 Americans, they add, died in 2007 and 2008 from the Chinese-made blood thinner heparin. 

Additionally, they estimate that 80 percent of the active ingredients in the nation’s pharmaceuticals are made abroad, where safety regulations are often much less stringent than U.S. guidelines.

Marcia Hams, prescription access and quality director at Community Catalyst, a Boston-based consumer group, said Tuesday that the wave of outsourcing — designed to benefit company shareholders — doesn’t always benefit consumers proportionately. Instead, she warned, “quality may be sacrificed in the drive to cut costs.” 

Michael Barr, a vice president of the American College of Physicians, said FDA’s oversight and enforcement of drug safety have been hampered by “chronic underfunding” and legal restrictions on the agency’s reach — limitations the Bennet bill would largely eliminate, he added.

“FDA needs to be given the tools to track where these drugs and products originate,” Barr said. 

FDA officials have signaled their clear support for reforms. In March, FDA Principal Deputy Commissioner Joshua Sharfstein told lawmakers on the House Energy and Commerce Committee that limitations on the agency’s authority has hampered its ability to safeguard the nation’s drug supply. Asked by Rep. John Dingell (D-Mich.), a long-time advocate of drug-safety reform, if FDA officials have the power to require drug makers to ensure the safety of their products, Sharfstein answered tersely. 

“No,” he said. 

“Do you have adequate authority to require mandatory drug recall?” Dingell asked.

“No,” Sharfstein responded. 

“Do you need that authority?”

“We would like that authority, yes.” 

“Would you like it, or do you need it?” 

“I would say we need it.”