BETHESDA, MD 13 January 2014—After decades of debate over how best to provide patients with information about their medications at the point of dispensing, FDA wants to place the primary responsibility for the process in the hands of drug manufacturers.
"We suggest that information about a manufactured product is best produced and tested by that manufacturer," said Janet Woodcock, chief of FDA's drugs division, during testimony on December 11 before the Senate Special Committee on Aging.
Woodcock was referring to patient medication information (PMI). Examples of PMI include leaflets that are packaged along with mail-order prescription products or attached to the bag in which a patient's medications are placed for pickup at a pharmacy.
Manufacturer-produced PMI is used in the European Union, Canada, Japan, Australia, and New Zealand, Woodcock said.
If implemented, FDA's plan would replace the current U.S. system through which PMI is created in electronic form by ASHP and other providers of drug information and used by community pharmacies to generate leaflets for patients. FDA does not review or approve the leaflets, but their content and format are subject to FDA standards.
FDA in 1980 finalized regulations for the content and distribution of PMI. But the agency revoked those regulations two years later, after manufacturers and other stakeholders assured the agency that PMI goals could be best met without federal regulation, Woodcock said.
FDA-funded research since then has shown that PMI has failed to meet federally established criteria for comprehensibility, readability, and legibility, according to a 2008 report prepared for the agency.
Gerald K. McEvoy, ASHP's assistant vice president of drug information, said FDA's new plan for PMI amounts to a system in which more than 800 manufacturers would independently create the documents with no editorial oversight.
"Although we agree with the goal of streamlining and enhancing the usefulness of PMI, we strongly disagree with FDA's plan," McEvoy said. "The FDA plan fails to ensure that patients will receive timely, accurate, consistent, and impartial information."
He said the problem of substandard PMI lies not with the quality of the drug information but with "substantial downstream alteration of both the content and format of PMI" by pharmacies and their technology vendors.
And he noted that PMI that was essentially unaltered before it reached the patient "exceeded FDA's content usefulness standard by over 20 percentage points," according to the 2008 report.
McEvoy said there are more workable approaches to PMI than what FDA has proposed, but FDA hasn't adequately considered those alternatives.
Doris Peter, associate director of the Consumer Reports Health Ratings Center, also urged FDA to rethink the plan for manufacturer-developed PMI.
"PMI should be delegated to an unbiased third party other than drug manufacturers," she testified.
At the time of the hearing, FDA had not yet proposed regulations to implement its new PMI plan. But Woodcock said that the agency wants to do so soon.
FDA's new framework for PMI development is based on the professional prescribing information that is created by manufacturers and approved by FDA.
Woodcock said that, ideally, PMI for each prescription medication would be presented in a single, standardized document analogous to the Drug Facts labeling for nonprescription medications and nutrition labeling for food products.
She said the agency is working with a contractor and several major manufacturers to update and maintain prescribing information so that the resultant new PMI will be "meaningful."
McEvoy said that, historically, FDA-approved prescribing information has not kept pace with important findings about drug safety, especially with respect to classwide warnings and consistency between brand-name drugs and their generic equivalents.
For example, he said, the labeling for 29 of 30 FDA-approved nitroglycerin products lacks the full classwide contraindication about using nitrates with erectile-dysfunction drugs that has appeared in the labeling for sildenafil since 1998.
Similarly, he said, although the prescribing information for simvastatin was revised in 2010 to include a warning about myopathy in patients of Chinese ancestry, the labeling for some generic versions of the drug "still does not include this critical risk information."
In his written testimony, McEvoy cited published reports that the median lag time for classwide boxed warnings to appear in prescription drug labeling is 5.5 years.
Under the so-called physician labeling rule (PLR) of 2006, FDA adopted a new, simplified format for prescription drug labeling. But just 15% of current labeling now uses that format, according to agency data from November 2012.
FDA had implemented a staggered schedule for manufacturers to use the PLR format. For drugs approved before June 30, 2001, compliance with the format is voluntary.
According to FDA, just 10% of the labeling for generic drugs–products that account for 80% of all medications dispensed–has been converted to the PLR format. The agency stated that it does not expect increased compliance unless something is done to encourage it.
About a year ago, FDA announced its intent to launch a pilot project through which a contractor would convert product labeling into the PLR format for review by manufacturers and eventual approval by FDA.
Horsham, Pennsylvania–based Reed Technology announced in October 2013 that the company had been awarded an estimated $26 million over five years to implement the PLR pilot project.
"What we're suggesting is a similar path to be pursued" for PMI, McEvoy said.
"Under a contracting scenario, FDA would have the needed control to ensure that PMI meets its new standards and would end up with much more timely, accurate, and consistent documents. In addition, the system would be far less costly than the one proposed by FDA and could be implemented more rapidly," he said after the hearing.
Woodcock said any plan by which FDA regulates PMI must require manufacturers to submit updated labeling information to the agency.
She also said FDA believes that the leaflets must undergo consumer testing to ensure that people "walk away with the right idea" about their medications.
She said that for FDA to contract out that process, the agency would have to pay for consumer testing for every PMI document.
"I think that is difficult in making that workable," she said.