Today the House Committee on Energy and Commerce held hearings on the heparin tainted drug. 

Testimony indicated that the heparin tainted drugs is close akin to the other drug counterfeit scandals of two years ago.  Six of the recommendations.

• FDA management system is at risk  The agency is unable to do more on a good day when it comes to inspecting the drugs. 
• FDA does not conduct enough foreign inspections.  They should be required to inspect to force the agency to balance the risks. 
• More money without requiring different outcomes will accomplish nothing.  The primary focus should be on the IT systems.
• FDA should move to account based approach to include life cycle of the products.  It should require submission of data to be cross-linked.  A unified approach.
• FDA should report to commissioner on imports.  A new organization should be responsible for import and trade negotiations and should be directly funded.
• The use of 3rd parties to get information on facilities that are not or never will be inspected by FDA.

Mr. Hubbard suggested that we need foreign supply vendor identification all the way back to the pig, inspect on site and improve IT system.

Mr. Neilson said that IT was the first problem.  A functional organizational structure to identify the problems such as foreign inspection oversight.  A funded organization is a necessity.  The funding needs to be attached to specific events.

Mr. England said that FDA is probably doing the best it can with the heparin events.  The inspections occurred after the adverse events, but based on the after event inspections FDA would probably not have allowed the drug.  Most of the foreign inspections were two day pre-approval inspections.  That may not be enough to find the problems.  Without the IT we cannot put together a risk based system.

Why would Baxter inspect the site and still import?  Apparently, Baxter did inspect.  They do have a responsibility to make sure the product is safe. 

Mr. Neilson added that there needs to be a re-evaluation of “good manufacturing practices.”  The current practice was written in 2003, but is too general.

The FDA is going to award a 2008 contract without the necessary criteria in place.  The contract will provide inspections, but there are no clear points from FDA if the inspection will require more than the fact that there is just a building on the site.

After listening to most of the hearings today, it seems that the FDA is broke and broken.  What a surprise!  The FDA has not gotten back to the Science Board after submission of improvements by the board.  The Science Board is available to help the FDA.  FDA has not answered the submission or requested help.

It was testified that we say if you don’t comply with our standards, we won’t accept your drugs or food.  The FDA should have this authority.  Obviously, not!

Institutional reform of the FDA is the only way to correct the problem.  Throwing more resources at the FDA will do nothing.  They need to be doing their job.  The testimony indicated once again that the FDA organizational structure was set up when we didn’t import.  When we started to import from other countries, there was some oversight, using domestic inspections.  Now, FDA has a division of import inspections and has no authority to do anything. 

The FDA has to undergo a transformational phase.  There seems to be a lack of commitment on the part of the FDA and they are perplexed by what the steps should be.  FDA has lost some of its best people.  The agency should be accessing priorities.

Well… we get the idea.  It is universally accepted that the FDA is broke and no one in the agency has the will or intelligence to correct the problem. 

 *Any typos or misspelling of names is apologized for, as this text came directly as the testimony took place.