Crackdown on 'off-label' pitches- national law journal- robert brady, meredith manning, and peter spivack

WHITE-COLLAR CRIME
Pharmaceutical companies have been penalized for pushing their products for unapproved uses.
approved off-label promotion. These cases further for the treatment of osteoporosis in highlight the fact that the DOJ is strongly and Peter Spivack SPECIAL TO THE NATIONAL LAW JOURNAL scrutinizing practices in pharmaceutical, IN A MAJOR SHIFT OF enforcement strategy, “Main Justice” in Washington and various (FDCA), the Anti-Kickback Statute Ind. Dec. 21, 2005).
signaled—via its most recent settlements over the course of two months—how Swiss company Serono S.A., along with its its enforcement will change the way U.S. subsidiaries, would plead to two bipolar disorder. The charges arose out of a criminal and civil charges related to qui tam, or whistleblower, lawsuit brought that Eli Lilly and Co. had agreed to plead Serostim. This represents the largest (FCA) by a former employee who painted guilty to a single misdemeanor count settlement to date for promoting a Food a picture of a “comprehensive scheme” charges and civil allegations related to product outside its approved indications, Neurontin for off-label uses. U.S. ex rel. the company’s marketing of its drug or “off-label” promotion. U.S. v. Serono Franklin v. Parke-Davis, No. 96-11651-PBS Laboratories Inc., No. 05d CR 10282-RCL (D. Mass. filed Aug. 22, 1996; settlement Peter Spivack are partners at Hogan & Hartson in Washington. Brady held several continues to expand the nature and extent leadership positions at the FDA. They of company conduct it will investigate, can be reached, respectively, at rpbrady and that it will pursue those investigations [email protected]. Associates Stephanie Solomon and Alison Stanton assisted in the Serono Labs pleaded guilty to two to settle liabilities relating to payments felony counts: conspiracy to distribute an made by state Medicaid and federal health care programs for Serostim during the time only be “reasonably foreseeable” that a device; and conspiracy to pay illegal of the illegal conduct. The government company’s conduct will result in a remuneration to health care providers agreed to allow Serono-owned companies to induce referrals to other than Serono Labs to continue receiving from civil claims related to the Serostim procedures spanning a variety of topics.
launched a campaign to The Serono CIA is similar to one in mass”—rather than weight loss, which Pfizer as a result of the Neurontin case, the company had used as the clinical but there are some notable differences.
size of the market for a particular endpoint in its clinical investigations First, the Serono CIA has a heightenedproduct that puts a company at risk of supporting approval of the drug—was the Nordisk A/S recorded only $2.6 million in the time of Serostim’s approval, protease Serono is obligated to implement policies sales of an insulin product for the first inhibitors also were approved by the relating to compensation to ensure that U.S. attorney for the Eastern District of AIDS wasting, and thus, the demand marketing practices. Finally, the Serono New York requesting documents related for Serostim. By “redefining AIDS CIA prohibits medical information to that product’s marketing and promotion.
Thus, health care companies in markets company aimed to artificially expand off-label information unless the request of all sizes need to be wary of the current In its case, Lilly agreed to plead guilty The Serono case arose from three boost lagging sales, the company initiated and to pay $36 million in connection with qui tam actions filed by former sales what it called a “6m-6 Day Plan” through its illegal promotion of its pharmaceutical which representatives were instructed drug Evista. In pleading guilty to a to offer financial incentives to high misdemeanor count of misbranding alleged that Serono sales representatives increase of $6 million within six days.
(BIA) test to “measure” patients’ body trips to the International Conference additional sum of $6 million. In addition, readings to suggest that patients without AIDS wasting be prescribed Serostim.
Cannes in exchange for the increased liabilities by entering into a consent Serono offered prescribers trips to Cannes, France, in exchange for writing a certain Serono will pay more than $560 million year’s sales of Evista in the United States company reduced the forecast of Evista’s ■ Organizing a “market research summit” The DOJ is watching first year’s sales in the United States during which Evista was discussed with from $401 million to $120 million, and physicians for unapproved uses, including an internal business plan noted a reducing the risk of breast cancer.
anti-kickback cases. In fact, the presence “disappointing year versus original forecast.” ■ Creating and distributing to sales of the kickback element in the Serono representatives an “Evista Best Practices” case appears to be the major differentiation to broaden the market for Evista by videotape, in which a sales representative states that “Evista truly is the best drug Lilly charging documents.
for the prevention of all these diseases,” referring to osteoporosis, breast cancer the FDCA, both cases demonstrate that preventing and reducing the risk of and cardiovascular disease.
the DOJ will not only prosecute promotion lacked adequate directions for use. Lilly’s alleges that Lilly used additional tactics, approved drugs for unapproved uses), but will Evista brand team and sales representatives including organizing “consultant meetings” thoroughly examine marketing efforts such for physicians at which unapproved uses for as Serono’s efforts to alter a diagnostic after the FDA rejected Lilly’s proposed drug in a wider patient population and Lilly’s labeling that Evista reduced “the frequency range of obligations on Lilly, similar to a promotional activities couched as “market of newly diagnosed breast cancer” in those research.” The cases also signal that the DOJ training and supervision of its marketing continues to closely scrutinize those activities also promoted Evista for the reduction and sales staff for Evista, and ensuring that considered “nonpromotional”—such as any future off-label marketing conduct is support for medical education and responses detected and corrected. Lilly agreed to be to unsolicited requests for information. A it is notable that a federal court granted component of any post-approval advertising Evista for any unapproved use. Lilly also breast cancer claim for Evista. Zeneca Inc. v. Lilly & Co., No. 99 Civ. 1452 (S.D.N.Y.
Evista and for complying with the consent Finally, the Serono case is the first known (tamoxifen) is approved for reducing most of the obligations under the consent evaluate or assess incentive compensation.
The Lilly case is the first in which the same conduct that AstraZeneca raised in its Importantly, the consent decree potential promotional tool. Both settlements Lanham Act suit—that Lilly used a number obligates Lilly to submit to the government all market research conducted by or for the ■ One-on-one sales pitches to Evista brand team or Lilly Market Research to promote drugs, biologics and medical physicians by sales representatives to measure physician recall of marketing devices, and that it will continue to apply promoting off-label uses for Evista. Sales messages by Lilly sales representative for Evista, along with any summaries, reports or This article is reprinted with permission from the prompt questions by doctors on presentations of such data. The consent March 20, 2006 edition of THE NATIONAL LAW JOURNAL. 2006 ALM Properties, Inc. All rightsreserved. Further duplication without permission ■ Encouraging sales representatives quarterly information on the interaction is prohibited. For information, contact ALM Reprint Department at 800-888-8300 x6111 or visit to send unsolicited medical letters to between their sales reps and physicians almreprints.com. #005-03-06-0008

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