Bioelectronics Corp (BIEL)

[Simpsonly]

Thanks for your post dolby and in post #43408 your reference to the "theory" Lishkod, because "work day" is not in the FDA nomenclature. I carefully researched this down to the nuts and bolts a while back and they use "FDA days" which they describe as defined as calendar days less any "hold" days, a hold day being a day while FDA is awaiting requested information from applicants, and the like.

The self imposed 180 day target by the FDA expired around August 22nd and Good Guy posters here have numerous e-mails from well-meaning FDA staffers indicating their sense of urgency to get 'er done "in a timely fashion". The longer period has led some of us to speculate that the Proposed Order is being substantially amended in positive ways because no one has come up with one iota of information about negative side-effects or efficacy issues.

One of the links recently posted directed us to an interesting article talking about allegations that the FDA is under the influence of big pharma, referring to such theories as Hollywood movie plot material and FDA fee influences as comical. I sometimes don't open such links, when pressed for time. I did this time and include the link and article below for those who didn't - I've had a little non-science experience in FDA application processes and I found it to be a good read and hope you do too.

QUOTE
http://www.forbes.com/sites/johnlamattina/2013/08/07/is-the-fda-being-compromised-by-pharma-payments/

Is The FDA Being Compromised By Pharma Payments?

In touting an upcoming special issue of the Journal of Law, Medicine and Ethics (JLME), Donald W. Light of the School of Public Health, University of Medicine & Dentistry of NJ, wrote an article entitled “Risky Drugs: Why The FDA Cannot Be Trusted”. Last week I discussed one aspect of this article, Light’s challenge that 90% of FDA approved drugs of the last 30 years are no more effective than existing drugs. However, the bulk of his essay focuses not on his views about pharma’s competence but rather on his issues with the FDA. While I found a number of his comments troubling, the following stood out.

“The forthcoming article in JLME also presents systematic, quantitative evidence that since the industry started making large contributions to the FDA for reviewing its drugs, as it makes large contributions to Congressmen who have promoted this substitution for publicly funded regulations, the FDA has sped up the review process with the result that drugs approved are significantly more likely to cause serious harm, hospitalizations, and deaths.”

This is a pretty damning comment. Basically, Light is saying that pharma paid congressmen to sponsor legislation that results in the FDA being beholden to pharma for funding for its work. Implicit in this is that, as a result of these large “contributions”, the grateful FDA is rapidly approving medicines that are harmful.

A bit of history would be helpful to show the actual reasons why the pharma industry makes “contributions” to the FDA. Few remember that back in the late 1980s there was a “drug lag” in the U.S. versus other parts of the world. Because of a lack of resources at the FDA, drugs were being approved at a much slower rate in the U.S. than in Europe. More than half of all drugs approved in the U.S. had been approved in Europe more than a year earlier. As a result, patients, physicians, advocacy groups, and pharmaceutical companies were all concerned that access to important new medicines was being denied to Americans.

To solve this problem, Congress enacted the Prescription Drug User Fee Act (PDUFA) of 1992. PDUFA provided a mechanism whereby charges were levied on pharmaceutical companies for each new drug application (NDA) filed. The revenues from these “user fees” were used to hire 600 new drug reviewers and support staff. These new medical officers, chemists, pharmacologists, and other experts were tasked with clearing the backlog of NDAs awaiting approval. Consequently, the FDA was able to reduce review times of NDAs to 12 months for standard NDAs and to 6 months for priority applications that involved significant advances over existing treatment. As a result of PDUFA, the timing of U.S. drug approvals began to mirror that of the rest of the world.

Congress clearly likes PDUFA as the act has been renewed five times since 1992. PDUFA-V was approved in 2012. Undoubtedly, this legislation helps to support the FDA and fuel needed growth. In 1995, The actual user fee charged to each company filing an NDA in 1995 was $208,000. In 2014, the user fee will be $2,169,100. If you assume that as many as 50 NDAs are filed in a year, Congress is passing on $100 million of FDA funding costs to the industry.

Despite Light’s assertion, I can attest that pharma companies don’t relish making these payments. The FDA is a government agency and should be funded entirely by the federal government. But pharma companies don’t have a choice. If a company wants to bring a new medicine to patients, it has to pay the user fee just to get the drug reviewed. Furthermore, anyone who pays attention to FDA behaviors knows that the agency doesn’t automatically approve NDAs. Just in the last few months, the FDA has rejected, in the form of complete response letters, an insomnia drug from Merck, a migraine drug from Allergan, and a kidney cancer drug from Aveo. In fact, any suggestion of the FDA being beholden to the pharmaceutical industry due to the PDUFA user fees is comical to those familiar with the drug review process.

So, why should anyone care about Light’s views? Unfortunately, as an academic whose work is supported by the Safra Center for Ethics, his word carries a disproportionate amount of influence. These comments perpetrate the view that there is an unholy alliance between the FDA and the pharmaceutical industry, an alliance that threatens the health of patients. This might make for a Hollywood movie plot. Truth be told, such a conspiracy doesn’t exist. UNQUOTE