Full article reprinted from "The Gray Sheet" - September 15, 2008
Find out why attorneys say until FDA finalizes guidance on what practices are acceptable in distributing journal articles that describe off-label product indications, companies should watch their step.
Full article reprinted from "The Gray Sheet" - September 15, 2008
Until FDA finalizes guidance on what practices are acceptable in distributing journal articles that describe off-label product indications, companies should watch their step in avoiding investigations that could lead to fines, criminal prosecution or exclusion from federal reimbursement programs, attorneys say.
While companies that petition the Department of Justice not to prosecute them for off-label promotion often cite existing laws and the FDA draft guidance, real-world conduct often does not fall under these protections, said Jeffrey Bucholtz, principal deputy assistant attorney general for the civil division of the U.S. Department of Justice.
"I really haven't seen a case come across my desk where the issue was just dissemination of reprints" or other situations covered by a 1999 federal court decision litigated by the Washington Legal Foundations that limited FDA's authority to stop manufacturers from distributing off-label scientific information (1"The Gray Sheet" Aug. 2, 1999, p. 3), Bucholtz said at a Sept. 9 panel discussion at the Food and Drug Law Institute's annual marketing and advertising conference in Washington, D.C.
"We hear about those cases all the time when people come in to pitch us about why we shouldn't go forward, but often, if you look at the conduct at issue in that [WLF] case, it's much more limited than the conduct that we unfortunately see in the real world," he noted.
At the heart of many industry defenses in off-label promotion cases are First Amendment claims, but these can often be irksome to DOJ attorneys, Bucholtz warned.
"If the promotion at issue is non-truthful and misleading, then the first Amendment has absolutely nothing to do with the case, because there's no First Amendment protection for speech that's not truthful or is misleading in the commercial context," he said.
While this defense may hold some water in cases, he continued, where a few sales people "on a couple of occasions get a little bit out of control and say things that the company doesn't know about and doesn't condone, if the company has a practice, has an approved sales script approved at a high management level and that sales script contains things that aren't true or that are misleading, that's a problem."
While the FDA guidance might offer companies some more clarification on these matters, Bucholtz said companies should take note that the guidance is in draft form, and that FDA could "finalize it, change it, or never do anything with it."
Guidance Could Be Delayed By Waxman's Interest
The draft guidance, issued in February, restricts dissemination by manufacturers to articles or publications that address "adequate and well-controlled" clinical investigations. It is meant to clarify FDA's policy on distribution of reprints or other documents that convey information related to non-agency-approved uses following the expiration of a section of the FDA Modernization Act that included safe harbor language for these activities (2"The Gray Sheet" Feb. 25, 2008, p. 7).
Industry defense attorney Lynn Shapiro Snyder recommends in the meantime that companies rely on guidance from their trade associations in how to approach the draft, and if companies disagree with what is in the draft, that they file comments documenting their opposition.
"If you intend to disregard and not go in accord to even a draft guidance because you feel so strongly otherwise, at least be on record as to why you were against it, and that way it helps to protect you at a later time during this time of uncertainty of what is the FDA's position," advised Snyder, Senior Member, Epstein Becker & Green.
AdvaMed is calling for the final guidance to be even less restrictive than the current draft version, arguing in April 21 comments on the draft that it is more limiting of the type of information that can be distributed and the scope of recipients than current laws (3"The Gray Sheet" April 28, 2008, p. 19).
How long the uncertainty remains is anyone's guess. In addition to the general unpredictability involved in FDA guidance development, the finalization of this document could be delayed further due to opposition from a powerful member of Congress.
Rep. Henry Waxman, D-Calif., believes companies will use the guidance as a free pass to promote their products for off-label uses in an unsavory fashion and is conducting an investigation into how the draft originated, Ann Witt, Health Counsel for Waxman's House Committee on Oversight and Government Reform, reiterated Sept. 8 during the FDLI meeting.
Waxman leaked the draft in 2007 in an effort to derail its development. Since then, he has looked further into how the guidance came about, how the guidelines were put together and who may have influenced them, Witt said. The House Committee on Oversight and Government Reform has also asked FDA how many full-time staff they anticipate will be necessary to enforce the guidance.
"We've received some internal documents; we've not received answers to many of the questions we've asked and are reviewing the documents now," she continued.
Waxman is troubled that the draft, if finalized as is, will diminish FDA's future enforcement authority as well as that of the Department of Justice and all the State Attorney Generals "who are out there trying to recoup the losses from Medicaid and Medicare from off-label promotion," Witt said, noting their current authority to use reprints as evidence of intended use, which the draft guidance does not make clear will continue.
How Off-Label Investigations Start, Move
But for now, DOJ and other government agencies are vigorously going after these cases and they are getting plenty of help from company whistleblowers.
DOJ investigations and investigations of off-label promotion by others nearly always start when a whistle blower files a qui tam lawsuit, Bucholtz said (4"The Gray Sheet" April 7, 2008, p. 13).
"It's not just that we decide to investigate it when a qui tam is filed, we have a statutory obligation to investigate it, and that's what we do," he noted.
When a qui tam is filed, it is distributed to the U.S. Attorney's Office for the district it was filed in to the fraud staff of the civil division at DOJ, Bucholtz explained.
If it is an FDA-related qui tam, it also goes to the DOJ office of consumer litigation, which does consumer criminal litigations under the Food, Drug and Cosmetic Act and to HHS Office of the Inspector General (OIG) and FDA.
Once at OIG, the qui tam is distributed to the office of investigations and the pertinent regional office of investigations, which then makes a decision about whether or not to assign an agent to the case, said Mary Riordan, senior counsel, administrative and civil remedies branch, Office of Inspector General, U.S. Department of Health and Human Services, during the Sept. 9 panel discussion.
In addition agents may be assigned from FDA to work with the OIG agent assigned to the case, Riordan noted.
"When it comes to the point in the case where it's time to make a recommendation and a decision about intervention, HHS is trying to speak with one voice to the DOJ," she said.
Factors Taken Into Account During Investigations
Bucholtz notes that every case is different. "Sometimes the relater comes to us with a lot of information in usable form that we can really work with. Other times not so much. Sometimes we have a lot of information about the matter because it may be related to a prior matter or pending matter that we already know about. Sometimes it's totally new to us, and so it takes longer to try to figure out what to do."
Considerations taken into account on whether to move forward with a case include whether the whistle blower is going to go forward and whether DOJ has the resources to bring a case, Bucholtz added.
OIG looks at whether misleading or false information was provided to the doctors or patients, including information about the safety or efficacy of the medical product or for the non-approved uses, Riordan explained.
"If approval was sought for a particular indication and denied and the company went out and promoted for that, those are good facts for the government," Riordan noted.
In off-label promotion investigations, OIG also looks at whether kickback issues or other bad conduct are involved and whether there is patient harm issues, Riordan continued. "That's an important factor for us, as is the extent to which the conduct led to increased expenditures for Medicare and Medicaid and other federal health care programs."
Bucholtz and Riordan both said that a company's willingness to work with FDA to come into full compliance with the related laws is helpful to the firm's case.
OIG and DOJ look at interactions between FDA and companies with "a fresh set of eyes," Riordan said.
"We'd want to understand exactly what was said, what was presented by the manufacturers, and try to probe around the edges a little bit to make sure that there wasn't some misleading information or lack of complete information that was given to the FDA, but we would certainly talk to the FDA about that situation."
Bucholtz noted that DOJ exercises prosecutorial discretion, and will not necessarily bring a case for which it has a provable criminal violation.
"We do very much want companies to work closely with FDA, we want companies to give FDA full and timely information of what they're doing, and if FDA responds to full and timely information, says 'sounds good to us, go ahead,' then it would be very odd for us later to say, 'Well that's a criminal case,'" Bucholtz said.
DOJ also consults with FDA to see if it is appropriate to bring a case, he added.
"So I think without there being any kind of stop-hold or veto ... the agency's evaluation would be important for us to consider."
- Ingrid Mezo
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