“Yesterday’s letter indicates that members of Tillis’ staff have been told that the FDA refuses to reply, which Tillis said he finds ‘unacceptable.'”
Senator Thom Tillis yesterday wrote to Food and Drug Administration (FDA) Commissioner Dr. Robert Califf, asking for a third time that the FDA conduct “an independent assessment and analysis of the sources and data that are being relied upon by those advocating for patent-based solutions to drug pricing.” Tillis expressed his frustration with the lack of response thus far, explaining that no formal reply has yet been received despite his first letter being sent in January 2022, and calling it “unacceptable” that the FDA apparently “refuses to reply to emails or to engage.”
Tillis’ initial letter was sent following a Policy Memo published by Professor Adam Mossoff in January, titled “Unreliable Data Have Infected the Policy Debates Over Drug Patents,” which targeted the Initiative for Medicines, Access & Knowledge (I-MAK), an advocacy organization that has become a “principal, go-to source” for data on the number of patents and patent applications covering pharmaceutical innovations.
According to Mossoff, I-MAK’s database of patents covering key drugs, and reports like Overpatented, Overpriced and America’s Bestselling Drugs of 2019, which are often cited by academics, including in law journals, policymakers and in congressional hearings, are flawed, and the vast discrepancy between the I-MAK and government data cannot be explained because I-MAK does not disclose or explain its underlying dataset, making its numbers “impossible to confirm.”
In his January 31 letter, Tillis wrote to I-MAK’s Tahir Amin, as well as then-Acting FDA Commissioner Janet Woodcock, expressing his concerns that the I-MAK data has created a “false narrative” that mischaracterizes patents as the source of high drug prices. In the letter to the FDA, he expressed his hope that an independent study of I-MAK’s sources could be completed by December 31, 2022. He asked Amin for “a detailed explanation of your methodology for calculating the number of patents on a drug product that could be replicable by other researchers.” I-MAK replied in March.
Tillis then wrote to the FDA again in April, supplementing his January letter with additional information based on I-MAK’s responses, which he said were not constructive and “instead largely repeated the same explanations it employs in its reports.” In that letter, Tillis asked for a response from the FDA by May 1, 2022, but has yet to receive one.
Yesterday’s letter indicates that members of Tillis’ staff have been told that the FDA refuses to reply, which Tillis said he finds “unacceptable.” He added: “Your prompt attention to this matter is greatly appreciated as having this valuable information before we begin a new Congress will ensure that lawmakers are armed with all of the key facts and the data needed to make sound public policy decisions regarding drug pricing.” He updated his deadline for a response to both the January and April letters to July 13, 2022.
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