Peter Barton Hutt, chief counsel, Food and Drug Administration, 1971-75

Peter Barton Hutt, now a partner in the food and drug practice of leading law firm Covington & Burling and a lecturer on food and drug law at Harvard Law School was, from 1971 until 1975, chief counsel at the U.S. Food and Drug Administration (FDA).

This is the position currently held by Daniel Troy, who was recently attacked for conflict-of-interest by New York Representative (22nd District) Maurice Hinchey, who, in a July 13th press conference and press release, criticized FDA for "inappropriate collusion or conflict of interest between Troy and the companies the counsel's office stood up for" and said that agency's "unsolicited insinuation into state civil suits represents a radical departure from the FDA's established practices, a fact Troy and the FDA have tried to obscure."

On the same day, Representative Hinchey introduced an amendment to the Fiscal Year 2005 Agriculture Appropriations Bill transferring $500,000 from Mr. Troy's office's budget to the budget of the Division of Drug Marketing, Advertising, and Communications in the FDA Center for Drug Evaluation and Research. The amendment was accepted by the House.

Mr. Hutt, as part of a bi-partisan group of five former chief counsels at FDA, begs to differ with Congressman Hinchey.

On July 21st, these five former officials sent a letter to Senator Judd Gregg, chairman of the Senate Health, Education, Labor and Pensions Committee, asking for the restoration of funds to the Office of the Chief Counsel at FDA, while also expressing their support for "additional funds for the Division of Drug Marketing."

In an exclusive interview today with Etopia Media Medical News Network, former FDA Chief Counsel Hutt discussed more fully some of the themes touched upon in the letter he and other former FDA chief counsels sent to Senator Gregg.

In that interview, Mr. Hutt makes the point that the FDA filing amicus curiae briefs is neither unprecedented nor inappropriate. He responded to Congressman Hinchey's implied position that the FDA is allied with the drug companies against consumers by saying, "that's sure news to the drug companies. They regard the FDA, as not the enemy, but as the toughest possible regulator and guardian of the public trust, and they are."

Mr. Hutt also both defended and explained the reasons for the FDA's position against drug re-importation, stressing the lack of FDA control over the manufacturing and distribution processes undergone by such re-imported products.

Asked whether what was needed to deal with many of the drug issues was an "international rule of law," Mr. Hutt said, "I couldn't agree with you more."

Citing $1.7 billion as the latest estimate of the cost of developing a new drug, he pointed out that, given the price controls applied by most other governments to drug prices, it is American drug consumers, especially the elderly, who are, de facto, subsidizing drug R&D worldwide

Mr. Hutt had to cut the interview short to go catch a plane, but he promised to continue the discussion next week. Y'all come back then.

You can listen to what former FDA chief counsel Hutt had to say today by clicking here.

Despite Mr. Hutt's defense of Daniel Troy's budget, there are others who, like Representative Hinchey, don't like either the current FDA chief counsel or the policies he rode in on.

For example, in a March, 2004, article in USA Vanguard, called "Insiders: The truth behind special interests, government", the reporter takes Mr. Troy to task for defending the tobacco companies and the right of drug companies to provide doctors with information about the "off-label" use of their products, a right the abuse of which recently led to a $430 million dollar fine against Pfizer in the case of their drug Neurontin®. More information about problematic "off-label" use of Neurontin can be found here.

Also lining up against the now obviously-embattled chief counsel are the folks at the Alliance for Human Research Protection, who, in an article entitled "Cong Hinchey Rebukes Daniel Troy, Chief Counsel FDA, for financial conflict of interest" write that Mr. Troy is "under fire for his financial conflicts of interest and for perverting FDA's mission."

And, finally, there's a March 24, 2003, piece entitled "Mr. Outside moves inside--Daniel Troy fought the FDA for years; now he's helping to run it" by Stacey Schultz in U.S. News & World Report. In that article, Ms. Schultz criticizes Mr. Troy on a wide range of regulatory issues.

Mr. Troy has his defenders as well as his detractors. Mona Charen, in her column today on the Townhall website, says that the FDA's chief counsel is only the latest victim of the fact that "Democrats fight dirty."