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Beginning in 2009, Eli Lilly and Merck will post in online databases all payments made to doctors for speaking and consulting services. According to an article in today’s New York Times, the postings will “likely include” the names of the doctors, or will provide some other identifying information about them, along with the reason for the payments.

The lack of disclosure by physicians about their relationships with drug and medical devices companies have  plagued medical journals and continuing medical education programs for many years. For those of you who may not know commercial and business relationships (including consulting and speaker fees) are common between leading medical thought leaders and drug companies. In the last two decades alone, drug and device makers have made payments to tens of thousands of doctors and researchers in all medical specialties and areas of research. Critics of these practices (including the US Congress) are worried that this money could taint doctors’ research plans or clinical judgment when it comes to new drug/device approval. These concerns have prompted government agencies, medical journals and universities to look more closely at the deals. Many medical journals and granting agencies now require that physicians disclose all of their relationships to drug and device companies before their manuscripts and grants are reviewed.

Lilly and Merck’s decision to publicly disclose which physicians are on their payrolls is a step in the right direction. Full disclose and more transparency about the relationships between physicians and drug/devices makers is an important first step to limit subjectivity and conflict of interest issues when it comes to new drug/device approvals.

Until next time….

Good Luck and Good Job Hunting!!!!!!!

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The Food and Drug Administration (FDA) announced today that it wants to hire 1,300 biologists, chemists, medical officers and others over the next several months. The agency currently employs more than 10,000 people and wants to add 600 new employees and backfill more than 700 that have been vacant by October. The new hires will triple the number hired from 2005 to 2007. Roughly 30% of all regular FDA staffers and approximately half of FDA managers are already eligible to retire.

An FDA spokesperson said that 400 of the new jobs will be related to drug application review and another 150 will be hired as inspectors to inspect drugs, foods and other related items. The agency will rely on user fees from drug companies to pay for all drug review jobs and about 100 other positions. The rest will come from the funds that were recently appropriated by Congress.

In addition to drug reviewers and inspectors, FDA is seeking consumer safety officers, nurse consultants, statisticians, epidemiologists, pharmacologists, pharmacists and veterinarians. Most of the positions are in the Washington D.C area but some are overseas and in other parts of the US.

This is one of the largest hiring initiatives in FDA’s history. It’s about time that Congress realized that the agency has been seriously under funded and understaffed ever since Bush was elected in 2001. I suspect that the impetus for the additional funding and hiring initiative has a lot to do with the beating that the agency has taken over the past few years. As we all know, FDA has been blasted by consumer advocates and lawmakers for lax oversight and inefficiency.

I can’t recall whether I said this before, but FDA is a great place “to be from”. Many of my colleagues who worked at FDA for three or more years are now highly paid regulatory consultants charging the companies that hire them about $3,000 to $5,000 per day. That said, as a bit of career advice; opportunity is knocking—don’t dither and wait too long before you apply.

Until next time….

Good Luck and Good Job Hunting (at FDA)!!!!!!!!!!

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