FDA DTC Review: The House that Troy Built

At the recent DTC (direct to consumer drug advertising) hearings in Congress, senator Stupak "alleged that Johnson & Johnson kept pushing its anemia drug Procrit as a fatigue-buster, despite the FDA's admonitions," according to this report. "Testimony on the subject came with a bunch of documents, which The Cancer Letter dug through--to find that the FDA's chief counsel may have intervened on J&J's behalf to keep the ads on the air."

According to the Cancer Letter:

"Internal FDA documents show that the agency made a series of unsuccessful attempts to stop a direct-to-consumer advertising campaign that claimed that Johnson & Johnson’s erythropoiesis-stimulating agent Proctit (epoetin alfa) improved “fatigue” associated with chemotherapy-induced anemia.

The advertising campaign, which is widely credited with making ESAs into the biggest-selling class of oncology drugs, was allowed to proceed with relatively minor changes after the FDA Office of Chief Counsel became involved in the controversy."

The FDA's Chief Counsel at the time was Bush-appointed Daniel E. Troy, who came on board in August, 2001 and who resigned in November, 2004, and is now a partner in the law firm of Sidley Austin LLP. That's him in the photo at the top of this post.

The timing of Troy's coming and going is important in terms of FDA's ability to review DTC advertising in a timely and effective manner.

At the DTC hearing last week, the Government Accounting Office (GAO) submitted testimony that documented, among other things, how long it takes the FDA to issue regulatory letters citing violative DTC materials. As the chart below shows, there has been a definite trend that correlates with the appointment of Troy.

(Click for enlarged view.)

Soon after being appointed, Troy instituted a legal review of regulatory letters before they were issued and this policy change effectively hobbled the issuance of these letters by the FDA. According to the GAO testimony:

"The primary factor that contributed to the increase in the length of FDA’s process for issuing regulatory letters was the additional work that resulted from the 2002 policy change. All DDMAC regulatory letters were reviewed by both OCC (Office of Chief Counsel) staff and OCC’s Chief Counsel. In addition to the time required of OCC, DDMAC officials told us that the policy change created the need for substantially more work on their part to prepare the necessary documentation for legal review. After meeting with OCC and revising the draft regulatory letter to reflect the comments from OCC, DDMAC would formally submit a draft letter to OCC for legal review and approval. OCC often required additional revisions before it would concur that a letter was legally supportable and could be issued."

As a result of this delay in issuance of letters, violative advertisements were often disseminated for several months before the letters were issued, according to GAO testimony. And by the time the letters were issued, more than half the violative ads/materials were already discontinued. Talking about closing the barn door after the cow has left!

Not only has it taken longer to issue regulatory letters after Troy's directive took hold, the number of letters issued has dropped as well. According to the GAO testimony: From 2002 to 2005, the agency issued between 8 and 11 regulatory letters per year that cited DTC materials. Prior to the [OCC] policy change, from 1997 through 2001, FDA issued between 15 and 25 letters citing DTC materials per year.

Troy's delaying legacy continued after he resigned, except for 2005, when there was a considerable dip in the number of months it took the FDA to issue letters. I attribute this dip to the Vioxx debacle in the fall/winter of 2004, after which the FDA was under pressure to do its job more effectively. As you can see, however, the ineptness of the FDA has recovered since then with a vengeance.

Former FDA Commissioner, Lester M. Crawford -- another Bush appointee -- who resigned 2 months after assuming office (and who later pleaded guilty of conflict of interest and false reporting of information about stocks he owned), said of Troy when the latter left the agency in 2004:

"In my estimation, Dan's principal legacy is having instilled in the Agency a deep and abiding respect for the rule of law, and for the limitations imposed on FDA by the Constitution, especially the First Amendment, and by our own enabling statutes. Dan embraced the responsibility, as befits an agency's top lawyer, of helping FDA achieve our public health mission with respect for the powers Congress has -- and has not -- given us."

Well Congress has given FDA new powers -- specifically it can now levy fines against companies for violations. However, if FDA cannot even issue warning letters in a timely fashion, how can it get past the OCC to levy such fines?

It's all good on paper, but smart-ass Bush-appointed lawyers and administrators know very well how to use paper to prevent FDA from using the powers given it by Congress. And yet they complain that they lack authority to do this and do that!

IMHO, the only way the FDA will ever be fixed is by getting rid of the do-nothing administrators, starting with the current commissioner. That's my opinion and I'm sticking to it!