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Senators: Enough study; take action on drug labeling


By Mari Serebrov
Washington Editor

Frustrated by years of study but no FDA rule requiring effective patient medication information (PMI) for prescription drugs, a Senate committee threatened to use the power of the purse to force some changes to protect patients from drug labeling mistakes.

The threat, which concluded a hearing held Wednesday by the Senate Special Committee on Aging, followed a testy exchange between Sen. Elizabeth Warren (D-Mass.) and the FDA’s Janet Woodcock about when the agency will finally propose a PMI rule.

In her testimony, Woodcock ran through the FDA’s long history of studies, public workshops and meetings with stakeholders on the best way to present drug safety information to physicians and patients. It’s a history that stretches back to the 1960s, with few rules implemented. For the past six years, the agency has been studying the use of a PMI that would replace the patient package inserts, medication guides and consumer medication information currently handed out with prescription drugs.

In response to a 2008 citizen petition requesting a single patient document that would more effectively communicate drug safety information, the FDA asked an advisory committee to weigh in, produced four prototypes, drafted a strategy to test those prototypes, called for comments on that strategy and held a series of expert meetings, public workshops and at least 18 meetings with stakeholders, Woodcock said in her submitted testimony.

Despite all that work, the FDA has yet to propose a rule on what information should be included in a PMI for a prescription drug, how it should look and who should put it together. (The agency implemented rules 10 years ago on providing patient information for over-the-counter drugs.)

Upset with the years of delay, Richard Scholz, managing member of Jacobs Scholz & Associates LLC, said stakeholders and policymakers have been talking about the need for patient-focused drug information throughout his pharmacy career, yet nothing has been done. “We have had too many stakeholder meetings, too many studies,” he testified.

Today, the FDA regulates what information drugmakers give to doctors, Warren said, but patients have no guarantee of getting the information they need about the drugs they’re prescribed. Citing a 2010 Centers of Disease Control and Prevention study, the senator noted that 15,000 patients die each year from unintentional overdoses, with many of those deaths probably due to lack of information about a drug.

Woodcock agreed that better labeling likely would prevent some of those deaths. She repeated the FDA’s past efforts, saying the agency would “try again soon” to propose a rule on how safety information should be conveyed to patients.

When Warren pressed her for a time frame, Woodcock said, “I can’t tell you when FDA is going to put a rule forward.” She added that it can take several years to get a regulation in place.


“If the FDA can’t commit to get this done in a reasonable time, then it’s time for Congress to act,” Warren said. “We’re talking about a fundamental safety issue here. . . . The FDA has had a long time to do this and a lot of people have died in the meantime. It’s time for us to do something.”

Committee Chairman Bill Nelson (D-Fla.) agreed, saying a good first step would be for the committee members to meet with Senate appropriators about including a measure in the FDA’s appropriations to force the agency to take action on improving drug labeling for patients.

Another committee member, Kirsten Gillibrand (D-N.Y.), introduced S. 752 in April that would require the FDA to issue rules, within two years, regarding the authorship, content, format and dissemination requirements for PMI for prescription drugs. The bill specifies what information should be included and requires the FDA to develop a public web-based database for all PMI.

Although no rule is on the table yet, the FDA has proposed electronic PMI that would be written by the manufacturers based on their FDA-approved professional labels. That proposal raised a number of red flags at Wednesday’s hearing.

Sen. Susan Collins (R-Maine) questioned a transition away from paper documents to electronic, noting access and security issues. She pointed out the problems that could arise during power outages, natural disasters and rural communities with spotty Internet accessibility. Then there are issues with computer literacy, hackers, viruses, etc., she said.

Scholz echoed her concerns, adding that electronic-only PMI would be problematic for pharmacists who may work on closed computer systems or who can’t interrupt their workflow to search the Internet for drug information. The problem with such health policy, he said, is that it’s focused on life inside the Beltway – not in real-life clinical practice. While she acknowledged the all-electronic PMI was just a proposal, Woodcock defended it, saying electronic media is the communication of the future, and young people want electronic information. Collins reminded her that older people are far more likely than young people to be taking prescription drugs.


Another red flag was raised over the idea of having drugmakers write the PMI based on their professional labels, which often are out of date. Gerald McEvoy, assistant vice president of drug information for the American Society of Health-System Pharmacists, presented several examples of drugmakers that took years to update their labels with important safety information. It is not uncommon to see different labeling in the same class of drugs, he said. For instance, it took up to 14 years for some makers of statins to include a required black box warning on their labels. Many generics also don’t keep up with the warnings on the brand drug, McEvoy said, which is problematic given the broad use of generics in the U.S.

Gillibrand also questioned basing PMI on a drug’s professional label, noting that even the FDA has acknowledged that such labeling is generally not up to date.

Although only 15 percent of professional labeling is current, Woodcock said the agency is working on getting the labeling of older drugs updated.