Senators introduced a bill Thursday that would require prescription drug labels to identify where the drug was manufactured, giving momentum to a years-long campaign to increase transparency in the elusive generic drug industry.
Members of the Senate Select Committee on Aging criticized drug companies at a hearing last week for routinely concealing the locations of drug factories and the suppliers that provide key ingredients. ProPublica explained this lack of transparency, and how the Food and Drug Administration enabled it, in a series of articles that revealed that the Food and Drug Administration had secretly allowed troubled foreign drug companies to continue selling generic drugs to unsuspecting Americans.
The transparent labeling law, introduced by Committee Chairman Rick Scott (R-Fla.) and Ranking Member Kirsten Gillibrand (N.Y.), is intended to help patients, doctors, and pharmacists learn more about the drugs they use and prescribe. Current labels often only list the distributor or repackager of the drug, and sometimes provide no information at all. The proposal would require labels to disclose the original manufacturer and the supplier that produced the key ingredient. Sens. Ron Johnson (R-Wis.), Tommy Tuberville (R-Ala.), and Katie Britt (R-Ala.) also signed the bill.
“Every American has the right to honesty and transparency about what they’re putting in their bodies,” Scott said. “It is completely irresponsible for us to live in the dark about where our medicines are made.”
ProPublica had to file public records requests and sue the FDA in federal court to obtain information about where generic drugs are manufactured and whether government inspectors flagged safety or quality concerns at those factories. Ultimately, ProPublica has created a first-of-its-kind tool that allows consumers to find information on their own.
Ninety percent of prescriptions in the United States are for generic drugs, many of which are manufactured overseas. It has traditionally been nearly impossible for patients and their doctors to determine where medicines were manufactured and the safety records of those factories.
ProPublica’s Rx Inspector tool, introduced late last year, includes factory location information and inspection history (where available) for about 40,000 generic drugs. Doctors, patients and researchers say they are already using the tool to better understand the origins of medicines and to find more information if generic drugs cause unexplained health problems.
The transparent labeling law would require manufacturing location information on the packaging of brand-name drugs as well as generic drugs.
John Gray, a professor at Ohio State University who testified at the hearing, suggested that the packaging could include a QR code that links to data on a website. Gray said he is working on assigning quality scores to specific versions of generic drugs, and that the code will make it easier for patients and doctors to find those scores when researching drugs and their manufacturers.
“Low-quality medicines have a negative impact on people,” Gray said.
Gray said he uses the Rx Inspector, which receives funding from the Department of Defense, as a driving force for his work. The tool “makes it easy to find out where your medicine is made,” he says.
The push for greater transparency follows a bipartisan report released last year by Scott and Gillibrand that called for fundamental changes to the FDA’s oversight of the generic drug industry. Among other things, the senators called on the FDA to warn hospitals and other institutional purchasers if foreign drug companies with serious safety or quality deficiencies are given special passes to send products into the United States.
Since 2013, the FDA has allowed more than 20 troubled overseas factories, primarily in India, to continue shipping certain drugs to the United States, even after those facilities were banned due to concerns about contamination and other violations, according to a ProPublica investigation. The agency did not actively track whether imported drugs were harming users and largely kept its actions hidden from the public and Congress.
Lawmakers also called on the FDA to conduct more drug testing. The agency does not regularly evaluate generic drugs once they are on the market, even if they come from factories with quality or safety violations. ProPublica recently tested several versions of three of the most widely prescribed generic drugs in the United States and found that two had defects that could put consumers’ health at risk.
At last week’s hearing, the committee’s fourth in recent months on generic drugs, lawmakers and witnesses said learning more about where drugs are manufactured is an important first step to improving drug quality. Pharmacists and members of Congress have long called for greater transparency to help patients and doctors make informed decisions about their health care.
Erin Fox, a pharmacist at the University of Utah Hospital, advocates for more information, saying, “Everyone has a right to know where their medicine comes from.”
Fox and others also said they support a drug quality rating system that would allow hospitals and government agencies to evaluate generic drugs based on quality, not just price.
“You would never go to the supermarket and buy the lowest priced bruised fruit, or you would never buy a one-star product on Amazon because it was cheap,” said Dr. Kevin Schulman, a professor of medicine and health policy at Stanford University. “Yet, that’s the generic drug market, and that’s 90 percent of the prescriptions we write as doctors. And that’s never acceptable.”
A spokesperson for the branded drug company trade association said in a statement to ProPublica that the industry “welcomes discussions about ways to strengthen the biopharmaceutical supply chain.” The generic drug lobby said additional labeling requirements would impose “significant costs in exchange for limited returns” and that drug companies already disclose country of origin information under U.S. Customs and Border Protection rules.
