FDA update

FDA will use computer tech to guide trial design

John Carroll — Tue, 16 Dec 2008 08:22:49 -0500

The FDA will deploy new computer technology from Entelos to simulate the activity of experimental medications so the agency can get an earlier read on the safety and efficacy of drugs in the pipeline. The Wall Street Journal reports that the FDA will announce the pact later today, highlighting how new computer simulations can be used to guide developers in the design of clinical trials. At a later point, the agency may also use the information it gleans to help define prescribing guidelines.

"What this study is about is trying to anticipate bad scenarios before they occur," Robert Powell, associate director in the office of translational sciences in the FDA's Center for Drug Evaluation and Research, told the WSJ. The new technology gives the agency a chance to better study the data gathered in a clinical trial by "plugging it into a virtual model of the disease." Entelos' Cardiovascular PhysioLab simulates the effect of cholesterol on the human body, illustrating the accumulation of plaque and likelihood of arterial rupture.

It also gives the FDA a better shot at heading off another safety fiasco like the one it experienced with Vioxx. And it's a big plus for the whole field of drug simulation technology, which has been wooing developers by touting its ability to look at how virtual humans will respond to a drug before they give it to living volunteers. The data is available in a matter of days and the FDA plans to start using it by focusing on the new drugs designed to treat cardiovascular conditions.

- read the story in the Wall Street Journal

FDA goes on hiring binge to fill research ranks

John Carroll — Tue, 16 Sep 2008 09:35:33 -0400

Chemists, biologists and microbiologists are among more than 1,000 people newly recruited into the ranks of the FDA. And more are on the way. Most of the new recruits are being assigned to the Center for Drug Evaluation and Research. The FDA is beefing up its workforce by about 10 percent overall as well as replacing retiring workers and has been on a recruiting drive since last spring.

So far, though, the FDA has fallen short on its goal to recruit more cancer specialists. An FDA official said that nine people had accepted job offers while 20 had turned the agency down. And money was the prime cause for their reluctance. Oncologists typically can earn around $400,000 and the FDA was able to provide only $275,000 a year.

It also remains to be seen how long the FDA can keep up its numbers. Past hiring drives have led to sudden surges in rank-and-file workers which have slowly melted away as new workers become disenchanted with low wage hikes common in government agencies.

- read the AP report

FDA suspends GMP requirements on trial drugs

John Carroll — Tue, 22 Jul 2008 09:42:22 -0400

The FDA has issued new guidelines that exempt Phase I drugs from certain Good Manufacturing Practice regulations. In issuing the exemptions--which go into effect September 15, the agency notes that GMP regulations were designed more for commercial manufacturing than for investigational products designed for a Phase I trial. The FDA's new guidelines mimic the same approach adopted two years ago which were suddenly withdrawn before taking effect.

FDA News notes that Phase I products will no longer have to meet GMP requirements for "a fully validated manufacturing process, rotation of stock for drug product containers, repackaging and relabeling of drugs and separate packaging and production areas."

- read the report from FDA News

Tougher FDA bars seven researchers from new studies

John Carroll — Tue, 10 Jun 2008 08:40:18 -0400

So far this year a more vigilant FDA has barred seven physicians from conducting medical research work. The actions equal the number of actions taken by the agency over the past three years.

The FDA has come under increasing pressure to take action against researchers accused of fraud. Critics have maintained that the agency often takes years before moving to bar a researcher from new studies. And one of the seven barred in the first half of this year was Maria Anne Kirkman Campbell, a researcher who admitted five years ago to research fraud in a Sanofi-Aventis study. An FDA spokesperson says the agency has adopted a new, tougher time line on such actions and is in the process of hiring new staffers to beef up enforcement.

- read the report in Pharmalot