On the last day of GRx+Biosims, David Gaugh, Executive Vice President of AAM, had a fireside chat with Robert Califf M.D., commissioner of the Food and Drug Administration. The Commissioner’s comments echoed many of the themes discussed by other industry and FDA participants during the meeting, especially regarding the worry about sustainability of the generic and biosimilar industry relative to the low (or, in some cases, nonexistent) margins on generic drugs and the slow uptake of biosimilars. In addition, the attempts by the innovator companies to thwart market entry through the patent thickets, as well as the reimbursement systems that PBMs employ, and the placement of drug, generic or biosimilar products into coverage tiers that disincentivize use of less expensive products, all of which contribute to lower demand for these products. Dr Califf noted that, with 90% of prescriptions being filled with generic medicines, there has to be a change in the reimbursement scheme in order to keep the industry healthy. While uptake of generic drugs is not a problem for small molecule drugs, he is a bit surprised that biosimilar products have not seen the same type of rapid uptake in the marketplace.

The Commissioner discussed the recent compliance reorganization and noted that the new inspectorate will be more efficient and take less time to make decisions, as the streamlining of the decision-making process does not need to go through as many different offices for concurrence and final action. He noted that the fact there are limited resources available to the FDA for compliance inspections and activities, there is no way that the FDA can get to all of the sites in their catalog as often as necessary, so alternate methods to permit the FDA evaluation of firms is here to stay. He specifically mentioned remote inspections as one method that has proved beneficial, especially for firms that have good compliance histories. He pointed out that the FDA needs to take advantage of the readily available data that firms can provide to support compliance with cGMPs. And remember, the inspectorate is not only for human drugs and biologics but also for veterinary drugs, manufacturing facilities worldwide, API suppliers, device manufacturers, tobacco compliance activities, as well as its inspectional responsibilities for foods.

Of course, MOUs and mutual recognition agreements with trusted foreign inspectorates are being used more frequently, but the FDA also needs to look at other potential avenues for informing their compliance decisions. He noted the possibility of using qualified third-parties for inspections to assist in those efforts but left that in the “maybe” category.

As was stressed by others at the meeting, he strongly noted that the CROs, practitioners, hospitals etc., who conduct bioequivalence and clinical studies need to do a better job of detecting data integrity issues. He said the Agency is watching this very closely and warned that those who cheat will be caught.

David Gaugh asked the Commissioner how User Fees help the Agency. Dr. Califf’s answer was not particularly surprising, as he said he did not like User Fees and noted the taxpayer should be the customer, and he felt (as I do) that appropriated funds should be used to fund the Agency’s needs. But he recognized that in the reality of the fiscal environment in which we live, User Fees are not likely to go away. Dr. Califf pointed out that the money paid to the FDA through the User Fee programs have been aiding in reducing times to approval and has helped dramatically in the area of scientific research and that the outcomes of the research has impacted application review issues.

One other observation he made was that, once a drug goes on the market approved for a specific indication, in practice it is likely to be used not only for its approved but for other off-labeled uses. “We as the FDA need to collect and analyze real world data (RWD)” to help assess the benefits of off-labeled uses. He suggested that with all of the data out in the practice world, the FDA should look to see if AI evaluation of RWD would be useful.

He left the audience with two thoughts:

    1. Be honest.
    2. Keep doing what you are doing with generics and biosimilars because it is the one thing that really holds down drug costs effectively.

 

With that, I will leave you to ponder some of the highlights of the meeting we have presented over the last few days, and suggest that in-person attendance at these forums is a great way to share ideas, speak to real live FDA folks (you may be really surprised that they are real people too), doing what they do from the regulatory side of the house to help lower drugs costs and assure that low cost products are available to the American public by continuing to approve safe, effective and high quality therapeutically equivalent and/or substitutable generic and biosimilar drug products.