FDA RETALIATION INVESTIGATIONS UNDER "INDEPENDENT" OUTSIDE PROCESS will be included in House legislation aimed at reforming FDA, House Commerce/oversight subcommittee Chairman Joe Barton (R-Tex.) promised in his opening statement during a Nov. 15 subcommittee hearing. "As this Congress moves forward on FDA reform...I will insist on an independent review process outside of FDA to handle cases" of alleged retaliation by the agency against industry, Barton said.

Barton cited a Nov. 14 Congressional Research Service memo as evidence of the "problems inherent in the FDA's administratively-created investigative offices" and, specifically, the agency's Office of Internal Affairs. CRS found that these offices "lack the protections that insulate the [HHS] Inspector General from outside influence and promote overall effectiveness," Barton said.

A number of "special features...tend to insulate the IG from outside influence and promote the overall effectiveness of the [Office of the Inspector General]," according to the CRS memo. These statutory features include presidential appointment of agency IGs; the requirement that appointees be named "without regard to political affiliation"; and the IG's "broad powers" to access documents.

Barton requested an analysis from CRS of the "legal issues relating to the delegation of responsibility to investigate employee misconduct allegations at FDA," the memo notes. Investigations relating to FDA were transferred from the HHS Office of the Inspector General to the FDA Office of Internal Affairs on Jan. 5. CRS reports that with "certain express reservations," the IG "issued a statement acquiescing to the delegation of these investigative functions" previously performed by the IG.

"The scope of mutual responsibilities and authorities of the [Office of Internal Affairs] and the IG have not been formally set forth in a memorandum of understanding between the two entities," the CRS memo states.

The "consequence of the failure to enter into an MOU" is to "open the process of investigating employee misconduct to a range of potential risks," CRS maintained. "Various problems and conflicts could arise," the memo states, "including minimal or erratic documentation in case files; incomplete or untimely reporting to the IG, agency head, Congress or attorney general; questionable decisions regarding a particular case; or other similar issues. The lack of formality could create an informal approach...in which investigations would be conducted."

"That description is not of an agency investigation system that is thorough and even-handed," Barton declared. "After reviewing [FDA's] prepared responses in light of information from the subcommittee's investigation, I do not think that the FDA is capable of investigating itself in an effective and impartial manner," he concluded.

Barton convened the hearing to question FDA Commissioner Kessler about allegations of FDA abuse of authority primarily focusing on medical devices. While admitting that the agency has made "some mistakes" in dealing with industry, Kessler testified that FDA has taken steps to "correct those mistakes and learn from those errors."

Kessler was the sole official witness Nov. 15, although he was accompanied by several agency officials, including Center for Devices & Radiological Health Director Bruce Burlington, MD, and FDA Chief Counsel Margaret Porter. Kessler told Barton: "I think that we have shown that we will take any misconduct on the part of anyone very seriously."

Barton indicated that he would continue to pursue the retaliation issue at an upcoming hearing scheduled for Nov. 29 on FDA censorship.

Barton identified several issues that he intends to pursue Nov. 29: whether FDA's Office of Internal Affairs has "significant authority to do internal investigations as opposed to the IG and HHS"; whether the FDA ombudsman's role is "strong enough to serve as an outlet for internal and external complaints"; and whether the "existing appeals process within FDA" regarding agency rulings is "effective" or an "outside appeals process" is needed.

In addition to allegations of FDA retaliation from several device firms, the July 25 hearing featured Houston-based lawyer Richard Jaffe, who testified on behalf of Stanislaw Burzynski, MD. Burzynski has used unapproved antineoplastons to treat advanced cancer and HIV patients; Jaffe told the subcommittee that FDA had conducted "two extensive raids" against Burzynski and had "impaneled at least four grand juries" to investigate the physician ("The Tan Sheet" July 31, p. 16).

The agency is "not at liberty to discuss the details" of the Burzynski case publicly since it involves an "ongoing criminal investigation," Kessler told the subcommittee. Commenting on the device company allegations, he testified that "we have found nothing in the record to support any of the specific allegations of retaliation that were raised at the July 25 hearing."

Kessler maintained that "in the end," positive change will result "from training" and "from role models, the higher-ups setting the tone."

Rep. Frisa (R-N.Y.) raised the issue of patient access to unapproved therapies during the Nov. 15 hearing. Kessler responded that patients "who have life threatening illnesses should have access to medicines as early on in the development as can be, especially those who don't have any other option."

However, "when we're at the very early stages, we should be able to do it through clinical trials...so we all learn about whether the medicine in fact works." He cited existing early access programs at FDA such as treatment INDs, accelerated approval and expanded access. "I think we can even do better," he stated. "My only request is that it be part of clinical trials."

FDA retaliation would be investigated by outside group under FDA reform bill -- Rep. Barton.

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