We are the guarantors of public health launched

The first statements by Margaret Hamburg, the new patroness of the Food and Drug Administration (FDA), were very expected. Speaking last week to an Institute of health officials (FDLI), this woman named by Barack Obama last spring sent signals very clear to the world economy, in particular pharmaceutical laboratories, which depend on it to be allowed to launch new drugs. "The new FDA will be more vigilant and more visible." "We are the guarantors of public health", launched.

This hardening is not a surprise. Several reports from the Government Accountability Office (GAO), equivalent of the Court of Auditors, have highlighted the shortcomings of the Federal Agency. Upon arrival at the White House, Barack Obama had criticized too lax found operation under the Bush administration. The "new" FDA should therefore be more aggressive and "get out his whip more quickly", according to the formula of an American analyst.

In fact, the strategy announced by the former head of the health of the city of New York sounds like a western title: faster, stronger. Now, the FDA will be more rigorously the benefit/risk ratio of new products (medical or food). At the same time, companies that "cross the line" will have to correct shooting as early as the first shot of wake-up call.

The Agency will also strengthen its so-called studies of phase 4 (after approval of the market). Objective: identify in vivo all adverse effects of a drug after its placing on the market. Patients under treatment will be encouraged to testify and all of this information will be made transparentes on the FDA site.

First banderilles

These new practices have begun by a few banderilles. The first touched the Wyeth Biotherapies specialist, now integrated in the Pfizer group. The approval of a new form of the vaccine antipneumococcique for child (Prevnar 13) has been postponed for three months for "lack of information".

The second warning is more serious. It is the world leader in generics, the Israeli Teva animal health division. After having found "significant violations" good practices in its plant American Saint Louis, the FDA has blocked the manufacture of the molecules in veterinary use of this site.

The US Agency was also highly anticipated a hot folder which stirs up over the years the research community: the management of conflicts of interest between the scientific world and the pharmacy industry. Since the beginning of the year, several cases have developed in light of the compromise between the hospital and laboratories. Subject matter: clinical trials highly paid by industrialists and tailor-made for their needs.

Ethics corner

In early August, FDA has set foot in the flat by publishing a long list of suspended or disqualified and temporarily banned from clinical researchers. These investigators are excluded to manipulated clinical data. Many American experts who attendaient this ethical turn believe however that the shift of a Mastodon in the size of the Food and Drug Administration will take a années. The Agency employs about 11,000 people and its budget (1.2 billion in 2008) is funded at 70 by the industry.