Most of our readers know that this characterization, assuming it was true for the 1980s-era (implanted 1987) device that the Court considered in Lohr, was no longer true, even at the time Lohr was decided, and certainly hasn’t been the case since the FDAAA was passed a year after Lohr was decided. (quoting from pro-plaintiff law review article). If the earlier device poses a severe risk or is ineffective, then the later device may also be risky or ineffective.” These determinations simply compare a post − 1976 device to a pre − 1976 device to ascertain whether the later device is no more dangerous and no less effective than the earlier device. “ubstantial equivalence determinations provide little protection to the public. 470 (1996), dismissed the §510k “substantially equivalence” medical device clearance as non-preemptive because it was supposedly “focused on equivalence, not safety”? Id. Hager’s complete explanation about the memo.Remember how Medtronic, Inc. As part of your investigation, we also request that the videotape be made available to allow Members of Congress and the American people to hear first-hand Dr. We urge you to commence an investigation into the serious issues that this memo has raised and make your findings available to the public as soon as possible. Unfortunately, the American people have yet to hear from Dr.

We asked Acting Commissioner Crawford weeks ago to make a decision about Plan B – yes or no. The FDA should never let political considerations interfere with scientific treatment decisions.ĭay-by-day, the public’s confidence in the FDA’s ability to make decisions based on scientific evidence of safety and efficacy is eroding.

Hager’s statements only add to our deep concern. Once again, what Satan meant for evil, God turned into good.”Īs we have previously stated, we are concerned that the FDA’s decision-making process is placing personal beliefs over science. For the second time in five decades, the FDA did not abide by its advisory committee opinion, and the measure was rejected… I argued from a scientific perspective, and God took that information, and he used it through this minority report to influence the decision. Hager states that “I was asked to write a minority opinion that was sent to the commissioner of the FDA. Hager to write a report, with the Washington Post reporting that he has given conflicting accounts to reporters. Hager stated in a videotaped sermon that he was asked to write a “minority report” outlining why over-the-counter sales of Plan B should be rejected. If substantiated, these allegations seem to leave little doubt that the process for considering Barr Laboratories’ application was based not on science, but on personal beliefs.īoth The Washington Post and the Nation report that Dr. Hager was requested to write the memo after an FDA Advisory panel voted in favor of making Plan B available over-the-counter. David Hager was asked to write a memo to the FDA commissioner about Plan B. We write to urge you to immediately initiate an investigation into reports in this morning’s Washington Post and The Nation that W. United States Department of Health and Human Services

The Senators reiterated their concern that FDA decision-making process was being driven by personal beliefs and ideology over science. David Hager to Acting Commissioner Lester Crawford on Plan B. (Washington, DC) - Senators Patty Murray (D-WA) and Hillary Rodham Clinton (D-NY) today sent the following letter to Secretary of Health and Human Services Michael Leavitt urging him to launch an investigation into a memo sent by Dr.

Memoranda of information fda