November 16, 2021
I’m Dr. Diana Zuckerman, president of the National Center for Health Research. I appreciate the opportunity to speak today.
My perspective today is based on my 30 years of working on issues pertaining to the safety and effectiveness of medical products. I have post-doctoral training in epidemiology and public health, and was a faculty member and researcher at Vassar, Yale, and Harvard before moving to Washington to work as a Congressional investigator on FDA issues in the U.S. Congress. I also worked at HHS and the White House.
Our center is a nonprofit think tank that scrutinizes the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products.
I am one of the FDA’s biggest fans, because I fully appreciate the agency’s importance. As a founding Board member of the Alliance for a Stronger FDA, I work with nonprofits and industry to increase appropriations for the FDA.
Our Center supports the GDUFA efforts to ensure getting safe and effective generic drugs to market as quickly as possible. We understand that FDA needs user fees to achieve that goal, because the appropriations have not been adequate to do so.
Today I want to focus on the safety and effectiveness issues in the GDUFA III Commitment letter. As you know, all the different user fee negotiations are behind closed doors, with public health, consumer, and patient groups excluded. During the pandemic, it has become even more obvious that public trust is eroded when the public feels it isn’t getting all the information it needs to make informed decisions.
Today’s GDUFA presentations have been focused on what industry wants and needs and what they are willing to pay for, and not on what patients and consumers want and need. Only one stakeholder comment was from a patient group, even though many patient and consumer and public health groups would have liked to have that opportunity.
Our healthcare is the most expensive in the world. The U.S. spends more than $3,000 more per person on healthcare than the second highest country, Switzerland. Without generic drugs, the cost of U.S. healthcare would be even worse. Trust in generic drugs is essential to help to make healthcare affordable. For that reason, we encourage the FDA to talk more about what you are doing to ensure that generic drugs are truly equivalent to brand name treatments in all the ways that matter to patients.
So, what are the metrics in the Commitment letter that are apparently most relevant to safety and effectiveness?
# 6. “Number of inspections conducted by domestic or foreign establishment location and inspection type (preapproval inspection, surveillance, bioequivalence clinical and bioequivalence analytical) and facility type (finished dosage form, API);”
# 7. “Median time from beginning of inspection to Form FDA 483 issuance;”
# 8. “Median time from Form FDA 483 issuance to Warning Letter, Import Alert and Regulatory Meeting for inspections with final classification of “Official Action Indicated” (or equivalent),”
# 9. “Median time from date of Warning Letter, Import Alert or Regulatory Meeting to resolution of the “Official Action Indicated” status (or equivalent); 10. Number of ANDAs accepted for standard assessment and priority assessment;”
# 12. “Number of citizen petitions to determine whether a listed drug has been voluntarily withdrawn from sale for reasons of safety or effectiveness pending a substantive response for more than 270 days from the date of receipt.”
#12 is more complicated, because of course citizen petitions are most likely to be needed when there is a problem that has not been clearly explained. So that could be seen as a failure. But on the other hand, if there is a citizen petition, it should be dealt with appropriately and in a timely manner and with meaningful results.
# 18. Percentage of facility re-inspections carried out within 4 or 8 months after the letter to the facility indicating FDA’s intent to reinspect for domestic or foreign facilities, respectively;
These metrics aren’t just important to patients, they are also important to industry. However, these examples are the ones that seem most relevant to ensuring that generic drugs and bio-equivalent drugs are as safe and effective as they could be.
Thank you for the opportunity to share my views with you today.