"FDA spokeswoman Ayse Yeaton told BioWorld Today that the agency sent nine hard copy letters and 89 e-mails to members of the public last week in response to inquiries and accusations about the lorcaserin panel."
I was one who received an e-mail response and I am recording it here for others to read.
On September 27, I emailed Capt. Mary Kremzner the following message:
Dear Capt Kremzner,
I thought you may be interested in seeing this online petition being promulgated regarding the lorcaserin panel review and effect on approval:
http://www.petitiononline.com/
--
R (Bud) T
On October 21, I received from MK, the following response:
Dear R(Bud) T-----,
Thank you for communicating your concerns to the U.S. Food and Drug Administration (FDA or the Agency) about the lorcaserin advisory committee meeting. As you know, on September 16, 2010, FDA held a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (Advisory Committee) to discuss the safety and efficacy of lorcaserin, a drug developed by Arena Pharmaceuticals, Inc. (Arena) to treat obesity. The Advisory Committee—made up of physicians, scientists, statisticians, and patient and consumer representatives— reviewed extensive background information prior to the meeting. The sponsor, FDA staff, and members of the public gave presentations during the Advisory Committee meeting. After thoroughly considering all the available information, the Advisory Committee voted 9-5 to recommend that FDA not approve lorcaserin for marketing.
After the Advisory Committee meeting, FDA began receiving correspondence from numerous parties questioning the views of FDA staff and comments made by FDA staff during the meeting, as well as accusations that scientists with appropriate expertise had not evaluated lorcaserin’s safety and efficacy data. FDA takes all comments and concerns about advisory committee proceedings seriously and wants to take this opportunity to address some of the concerns about our policies and procedures.
FDA achieves its mission to protect and promote the public health through rigorous evaluation of all data submitted in support of a new drug application (NDA). Often, the data submitted raise challenging or novel scientific issues relating to the drug’s safety and/or efficacy. FDA advisory committees serve an important function by providing the Agency with an independent, expert evaluation of the data during the drug review process. FDA ensures that during the meeting, the full spectrum of views of the data are presented to the committee and that all committee members have the opportunity to ask questions and present their own views on the data. FDA staff also routinely present their own reviews, conclusions, and individual perspectives of the data. This practice ensures that differing opinions are transparently presented and debated and allows the committee to make recommendations after taking into account all perspectives. This public process helps FDA obtain expert advice during the review process and increases the transparency to those with an interest in a particular matter. Although FDA highly values the opinions of the independent experts on the committee and often incorporates those opinions into its decision-making process, FDA makes the final decision about whether a drug should be approved. Advisory committee votes and recommendations are not binding on the Agency.
FDA has strict rules governing conflicts of interest for both employees and advisory committee members. With certain limited exceptions, FDA employees and their families cannot hold a financial interest in any company that is significantly regulated by FDA. FDA employees must report their financial interests on a yearly basis and their reports are reviewed by Agency ethics staff. FDA has not been made aware of any evidence to suggest that these rules were not followed by the FDA staff at the lorcaserin Advisory Committee meeting.
Similarly, advisory committee members must report to FDA any financial interests they hold related to the subject matter of the advisory committee meeting. FDA screens advisory committee members broadly for financial or other relationships that could present even the appearance that they have conflicts of interest that could affect their impartiality. For the lorcaserin meeting, as with all advisory committee meetings, all Advisory Committee members were appropriately screened for conflicts of interest.
Although FDA strives to have broad representation of appropriate medical and scientific specialties on its advisory committees, optimal representation is often difficult to achieve given the strict conflict-of-interest regulations that apply, as well as calendar conflicts, which may limit the availability of experts for the selected meeting dates. The lorcaserin Advisory Committee included representation from the fields of Endocrinology, Cardiology, Pharmacology, Health Policy, Epidemiology, Biostatistics, Internal Medicine, and Clinical Research. In hindsight, FDA regrets that no toxicologist participated in the meeting. However, a team of FDA toxicology experts reviewed the lorcaserin NDA and interpreted the data related to the lorcaserin carcinogenicity studies. Moreover, the lorcaserin carcinogenicity studies were also thoroughly reviewed and discussed by the Center for Drug Evaluation and Research (CDER) Executive Carcinogenicity Assessment Committee, and the results of this scientific assessment were included in the background documents provided to the committee and discussed in Agency presentations at the Advisory Committee meeting.
Consistent with the FDA’s policy on transparency, FDA announces the dates for advisory committee meetings in advance through publication of a notice in the Federal Register, and the Agency posts all advisory committee briefing materials on its public website 48 hours prior to the meeting. Prior to the public posting of the documents, they are kept in strict confidentiality with only the advisory committee members and the sponsor having the opportunity to review them. As soon as possible after an advisory committee meeting has concluded, a transcript of the meeting is made available on FDA’s public website. In this way, the diverse views of all participants, both FDA employees and advisory committee members, are made available to the public.
After obtaining advisory committee input on an NDA, FDA completes its review of the application and communicates its findings to the sponsor. FDA considers all of the data contained in the application and conducts its own independent analysis of the data before making a decision as to whether the benefits of the drug outweigh its risks for the proposed use. FDA believes that this rigorous review process leads to the most appropriate decisions about the safety and efficacy of proposed new drugs.
FDA remains committed to ensuring that its advisory committee process is conducted according to applicable statutes and regulations and will continue to make these proceedings transparent to the American public. With regard to the specific allegations made against FDA staff, FDA will continue to review these allegations and if misconduct is identified, will take appropriate action.
Again, we appreciate you taking the time to express your concerns.
Sincerely,
Division of Drug Information LC
Center for Drug Evaluation and Research
Food and Drug Administration
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A lot of boilerplate here, but I think we got our message through and it had on effect on the CRL sent to Arena. It also reached the media that an unprecedented amount of investor watchfulness has been established in ARNA. This can largely be attributed to the Yaho0 Message Board and this Blog Site.
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