Agency takes aim at Myoview and Miraluma materialsThe Food and Drug Administration has been casting a critical eye over the promotional efforts of two radiopharmaceutical companies, Amersham International and Du Pont Merck Radiopharmaceuticals.
Agency takes aim at Myoview and Miraluma materials
The Food and Drug Administration has been casting a critical eye over the promotional efforts of two radiopharmaceutical companies, Amersham International and Du Pont Merck Radiopharmaceuticals. Both companies are in the process of responding to FDA enforcement actions related to their products: Myoview, a cardiac imaging agent sold by Amersham, and Miraluma, a breast imaging tracer marketed by Du Pont Merck.
The FDA's actions in the case of Amersham are the more serious of the two, with the agency sending a warning letter to the company's Amersham Healthcare U.S. subsidiary in Arlington Heights, IL, charging that the company was promoting Myoview for unapproved uses. In Du Pont's case, the North Billerica, MA, company received a notice of violation, which is not as serious as a warning letter, asking the company to change marketing materials that the FDA felt were misleading.
The Myoview letter was sent Aug. 21 by the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC). In it, DDMAC director Minnie Baylor-Henry took issue primarily with two aspects of Amersham's promotional materials for Myoview, one of which regarded Amersham's claim that Myoview could be used with pharmacologic stressors and the other a claim that Myoview can assess ventricular function along with myocardial perfusion in the same SPECT study.
The FDA believes that Amersham has not submitted evidence demonstrating that Myoview is safe and effective with pharmacologic stressors, nor has it submitted evidence that Myoview is safe and effective for procedures to address ventricular function. The letter asks Amersham to develop an action plan to correct the promotional materials. Such a plan should include the withdrawal of the promotional materials and the development of a "Dear Healthcare Professional" letter that would be mailed to physicians and run as a paid advertisement in journals that contained ads for Myoview over the last 12 months.
Amersham has responded to the FDA's concerns, and plans to discuss the issue with the agency over the next several weeks, according to William Ehmig, vice president of professional affairs for the company. While Amersham is cooperating with the agency, the company believes that some of the FDA's concerns are the result of a misunderstanding.
"You don't like to get letters from regulatory agencies, but we think that there are some misunderstandings on their part, and it's not so serious as it's been made out to be," Ehmig said.
Ehmig declined to comment specifically on the FDA's allegations until the company had a chance to review the case with the FDA.
With respect to Du Pont Merck, the company received its notice-of-violation letter in June, not long after it launched its campaign for Miraluma, a scintimammography agent based on the company's Cardiolite heart imaging agent (SCAN 6/11/97). Also from the DDMAC, the letter objected to statements made in a press release announcing Miraluma's launch, as well as in materials distributed in Du Pont Merck's booth at the Society of Nuclear Medicine meeting in San Antonio.
Among the statements to which the FDA objected was Du Pont Merck's claim that Miraluma was useful for visualizing difficult-to-image breast tissue, which the FDA believed was unsupported by the data submitted by the company, according to the letter.
"The approved product labeling for Miraluma states that images from dense and fatty breast tissue were similar, and studies were not designed to compare the performance of Miraluma with the performance of mammography in patients with breast densities or other coexistent breast tissue disorders," the letter states.
The FDA also believed that Du Pont Merck made statements claiming that Miraluma was superior to x-ray mammography for women with dense breasts, which the agency likewise saw as unsupported, and it also questioned Du Pont Merck's use of in vitro data to explain how Miraluma accumulates in areas of malignant cells. In addition, the letter objected to the semantics of some terms used in Miraluma's promotional materials, which the agency believed had meanings not covered by Miraluma's product labeling.
Du Pont Merck has responded to the FDA's letter and is discussing the agency's concerns, according to Andrea Scibelli, public affairs manager. The company has agreed to change some of its promotional material in line with the FDA's advice, but will clarify its position in some areas, such as whether "abnormal" and "inconclusive" are synonymous terms.
"There were some points where we wanted to discuss their comments further, and there were points where we've made concessions," Scibelli said. "We've welcomed the opportunity to talk to them about this, because this was the first time we'd positioned the product and promoted it."