When seven biopharma executives were asked by senators in February whether they had intentionally blocked generic competition, all of them said no.
But several of the companies’ products were included in a recently updated list
from the US Food and Drug Administration (FDA) showing inquiries to the agency from prospective generic applicants indicating that they would like to develop a generic, but are unable to obtain the necessary samples of the reference listed drug (RLD).
In recently released written comments from the February hearing, Sen. Chuck Grassley (R-IA) asked Pfizer CEO Albert Bourla: “Could you please explain in detail why Pfizer is on the FDA list?”
Bourla, following Pfizer’s letter last May to FDA Commissioner Scott Gottlieb on the list, explains why it may be misleading.
While supporting FDA’s goal of transparency, Pfizer said it “is concerned that the List lacks certain key information and context and, as currently presented, may create the misleading impression that all products on the List are the result of bad faith attempts to block generic manufacturer access to samples.”
Pfizer notes how the list also lacks important details to enable a New Drug Application (NDA) holder to investigate its appearance on the list. And in Pfizer’s letter to Gottlieb, SVP Peter Honig explained how on the website there’s “no indication as to whether an applicant who complained about not having access to such a drug product took appropriate steps to facilitate its access to the product when there was such a REMS in place.”
But in its response, FDA Center for Drug Evaluation and Research Director Janet Woodcock explains how the website
makes clear that FDA has not independently investigated or confirmed the access limitations.
AstraZeneca CEO Pascal Soriot similarly told Grassley: "It is our understanding that BRILINTA was included on the RLD List based on a single inquiry received by the FDA. Unfortunately, the RLD List does not identify the company that reportedly requested information (or samples) from AstraZeneca, the date the information was requested, or any other information that would allow AstraZeneca to better understand or further investigate the circumstances of this inquiry."
The company also explained how more than 15 generic manufacturers have applied for FDA approval for the manufacture of generic Brilinta. "Because conducting bioequivalence studies with the branded medicine is an FDA pre-approval requirement, it is clear that these generic manufacturers are not having difficulty accessing branded ticagrelor for their studies."
Similar to Grassley, Sen. Bob Menendez (D-NJ) questioned J&J on the discrepancy between its subsidiary Actelion's appearance on FDA’s list and comments made at the hearing.
J&J’s EVP Jennifer Taubert, while noting that J&J acquired Actelion in June 2017, said FDA’s website on RLD access inquiries does not differentiate between inquiries and complaints, and does not clarify whether the RLD sponsor made samples available after the FDA issued a Safety Determination Letter, which states FDA’s determination that the generic company’s study protocols include safety precautions for testing comparable to those set forth in the RLD’s REMS.
“Following the receipt of a Safety Determination Letter from the FDA, Actelion has actively entered into a supply agreement with every generic manufacturer who has requested testing samples of our products,” Taubert added.
Article updated with more information on AstraZeneca.