Scott Gottlieb, MD hosted a three-person panel on the closing day of the GPhA Annual Meeting just before Dr. “Cook” Uhl presented the Office of Generic Drug (OGD) update. Scott fired questions at Kate Beardsley (Beardsley Law PLLC), Sheldon Bradshaw (former Chief Counsel FDA and now a partner with Hunton and Williams LLP), and Frances Zipp, (President and CEO, Lachman Consultants).
Generally, the group acknowledged that, although OGD and Office of Product Quality (OPQ) were doing better, there were still a number of areas that are causing considerable tension between the groups and are in need of improvement. Among the top issues were transparency, consistency of reviews, and the inspectional process.
Mr. Bradshaw noted that GDUFA goals that are judged on the issuance of complete response letters (CRLs) missed the mark that the Agency should be judged against (albeit that’s what appears in the Goals Letter) and noted that OGD should strive to approve generic products at the first opportunity that they can be legally approved. He also complained about lack of communication between the time an application is accepted (received) for review and the issuance of a CRL. However, that was countered by Cook when she presented data indicating that OGD is issuing about 500 Information Requests (IRs) and Easily Correctible Deficiency (ECD) letters a month.
The group also addressed the issue of long review times for complex drug products, as Gottlieb’s questions touched a nerve with both the panel and the audience. Ms. Zipp noted that, when an NDA is approved that contains a complex API, they have to prove to the Agency that their product is safe and effective and that the manufacturing process is reproducible within certain limits. The innovator has not historically been required to fully characterize the API or the finished product. However, the generic applicant must also demonstrate the “sameness” of its API and product, thus performing the task of full characterization of the material. Perhaps the new drugs review group should also place the responsibility of characterizing its innovator product to make the entry of generics easier.
All three participants acknowledged that there is a tension between OGD and industry, but as Kate noted, this tension will improve if the rate of approvals continues to rise and that communication gets better. The issue of quality of the ANDAs was also raised as a concern from FDA, but the panel retorted that the quality of the FDA reviews also needs to be judged. Ms. Zipp noted that many firms take the time to categorize deficiencies they receive in an IR, ECD, or CRL and incorporate these items into their next ANDA, but are then surprised to receive an entire set of new questions turning the review process into a never-ending story of sorts. This all goes back to consistency in review and FDA outlining what is necessary for approval versus what are “nice to know” or academic curiosity questions!
As a whole, there was a sentiment among the panelists that, while OGD has delivered on the goals of the GDUFA Goals Letter, they have not yet delivered on the goals of Hatch-Waxman to get products to the market at the earliest date they can be legally approved.
More on the OGD presentation from Cook tomorrow.