I’m Dr. Diana Zuckerman, president of the National Center for Health Research. Our nonprofit think tank knows recognizes that generic drugs are the foundation of our healthcare system, making the regulation of these drugs the most important work of this very important agency. GDUFA deserves much more attention than it has received from Stakeholders. Because all of us are Stakeholders because we all use generic drugs.
We appreciate that GDUFA has reduced the backlog of generic drug applications. Everyone agrees that was an important accomplishment.
We have a growing concern that the FDA has won an important battle but lost the war – public trust.
The value of generic drugs is based on trust. Some patients doubted they were just as good, but doctors trusted them.
That’s changed.
More than a year ago we submitted a public comment to recommend enhancements to GDUFA IV to strengthen public trust in generic drugs. Despite considerable agreement among patient, consumer, and public health groups at the GDUFA Stakeholder meetings, none of those recommendations were included in the commitment letter.
Why the loss of trust? In its series of devastating investigative news articles, nonprofit the ProPublica reported years of problems that the FDA discovered during foreign inspections.
For example, despite a ban due to egregious problems at Sun Pharma, more than 2 dozen drugs were shipped to the US and sold. Pills and injectable medications that otherwise would have been banned went to unsuspecting patients across the country, including those with cancer and epilepsy.
Did the FDA at least routinely test these medications for quality problems or track complaints from patients? Former CDER Director Janet Woodcock was quoted saying “We felt we didn’t have to make it a public thing.” Those of us who know her aren’t surprised at her honesty.
In another example, the FDA determined that a testing company in India named Synapse “faked and forged” data submitted to the FDA.
FDA withdrew the bio-equivalency rating of 400 drugs that were tested by Synapse, but those drugs stayed on the market for over a year. Patients weren’t warned.
This decision was very dangerous for patients and was also unfair to companies whose safe and effective generic medications were competing with those 400 drugs. And it is unfair to all generic companies that make excellent medications when patients don’t know which generic drugs they can trust, and which they can’t.
Meanwhile, Valisure conducted research showing a sizable number of generic drugs are substandard, with doses that are too high, too low, or drugs that are contaminated or have other problems.
FDA should be on the forefront of conducting that kind of testing and notifying the public of results.
At the Stakeholder meetings, several of us recommended that GDUFA pay for more inspections, more post-market testing, and for staff who will warn patients and pharmacists about specific dangerous generic drugs.
That didn’t happen.
The Commitment letter may help improve some inspections, and having more manufacturing facilities in the U.S. might be safer, but it does not address the need for FDA staff to accurately compile and publicly disseminate information about generic drugs that are potentially dangerous or ineffective.
I want to mention that we support Dr. Michael Abrams’ recommendation that the GDUFA commitment letter should include an FDA-based reporting structure that informs the public when manufacturers fail inspections.
ProPublica created its own manufacturing database to fill this gap last year. If ProPublica can do that, surely the FDA can and should do it, with its access to information that nobody else has.
To regain public trust, we urge the FDA to add performance goal metrics that focus on safety and equivalence in GDUFA IV in the ways I’ve suggested.
We also agree with Dr. Abrams that GDUFA should make regulatory commitments to optimize the disclosure of Drug Master File information so that generic makers can release “pharmaceutically equivalent” drugs as quickly as possible after the last patent on a drug expires. This should include the active ingredients as well as the inactive ingredients.