The Food and Drug Administration will soon complete the second stage of a three-phase process to increase public transparency of agency activities and decision making. Last week, the FDA’s new Transparency Task Force concluded a three-month comment period on 21 bold new proposals to expand the agency’s disclosure practices. Community Catalyst, with the support of prominent drug safety experts Drs. Joseph Ross and Aaron Kesselheim of Yale University Medical Center and Harvard Medical School, respectively, filed comments endorsing many of these proposals with respect to prescription drugs, and recommending other improvements to promote public health and empower patients and consumers.

Seeing Clearly Now – The Importance of Transparency

The FDA task forces sees increased transparency as part of new Administration’s Open Government Initiative, and as a means to build public confidence in the FDA by making the agency’s activities and decision-making more accessible and understandable to consumers, providers and other public health experts. These 21 proposals would significantly increase access to information in nearly all areas of prescription drug regulation, from developmental studies to inspections of manufacturing and import procedures to adverse reactions experienced by patients.

Many of these common sense proposals are especially timely in light of the recent revelations about drug makers withholding critical information about drug safety studies and manufacturing problems.

For instance, the FDA recently made public a report summarizing 12 manufacturing violations and other inspection findings concerning a Johnson and Johnson plant in Lancaster, Pennsylvania. This is notable as it was the third Johnson and Johnson plant to be cited for violations this year, the same year in which the company has recalled over 130 million bottles of children’s medication due to possible contamination. A congressional investigation recently found that in June 2009 the company’s McNeil division sent in contractors to surreptitiously buy up potentially contaminated Motrin, rather than issue a formal recall of the product. One new transparency reform being considered by FDA would make information on inspections and violations at manufacturing facilities open to the public. This would inform consumers about when FDA uncovers problems in the manufacturing process—or when a company has a clean record. Increased public scrutiny of problematic industry manufacturing practices will alert consumers when problems arise, and also help force manufacturers to prioritize quality improvement.

Also of great interest to the drug safety and patient community are the proposed disclosures of the status of product applications and the release of summary clinical trial data on drug safety and effectiveness. Such information would notify patients awaiting the development of new drugs on the industry’s efforts and safety concerns and help prescribers make informed decisions. Most importantly, the disclosure would also allow independent researchers to conduct their analyses in order to complement FDA and industry research.

The recent revelations that GlaxoSmithKline withheld studies documenting the cardiac risks associated with their blockbuster drug Avandia, and selectively excluded negative data from other published studies demonstrates the need for full transparency.

GSK’s actions were nearly identical to drug maker Merck’s withholding of studies documenting the cardiac risks of Vioxx, which is estimated to be responsible for tens of thousands of heart attacks. In both cases, lack of access to this data meant that it took years for the health risks of these products to come to light.

Even so, under the current scheme, FDA sits atop a mountain of clinical data submitted with marketing applications that may help identify risks sooner. Had comprehensive clinical trial data on Vioxx and Avandia been available to independent researchers earlier, health risks associated with these drugs could have been discovered and publicized much earlier. Lives could have been saved. The FDA simply does not have the resources to perform all the analyses that independent investigators can.

These safety issues, coupled with recent manufacturing problems that have undermined the integrity of our drug supply chain, demonstrate the need for expanded FDA disclosure of drug approval information and inspection results.

Will it be a Bright Sun Shiny Day?

Aside from supporting the FDA’s bold new approach to increase transparency, we also recommended that the FDA go farther in some areas. For instance, we feel that the FDA’s proposal to disclose the scope and completion of a food recall be expanded to include any recall of prescription drugs, as well.

And while the FDA has proposed future meetings to discuss the disclosure of non-summary (or individual level) data from drug trials, we argued that the need for public access to this data is beyond dispute because it allows independent researchers to more quickly complete objective drug safety analyses that reveal risks and thus sound the alarm on patient safety issues.

(Tune in tomorrow to learn what other consumer advocate, and the drug industry said about these vital transparency reforms.)

— Ian Reynolds, Policy Associate — Joy Lee, Policy Intern