Medical Device Daily Washington Editor

The FDA proposal to divulge clinical trial data as a means of speeding diagnostics and therapeutics to market continues to draw fire, and Boston Scientific (BSX; Natick, Massachusetts) said in an Aug. 5 statement that the release of trade secrets and confidential commercial information could "impede global innovation in the medical device space." The widespread resistance to the proposal seems to suggest that investors might pull back from med tech if the agency follows through, and thus reduce research and development into devices and diagnostics, a trend that would run precisely counter to the agency's goal.

BSX is not the only corporate entity to question the legality of the proposal. Novartis Pharmaceuticals (Rockville, Maryland) also raised the issue (Medical Device Daily, Aug. 8, 2013), and BSX's Tamimi Itani, PhD, the company's VP for global regulatory affairs, seconded that concern on similar grounds. Itani said in the firm's Aug. 5 response to the docket that BSX's "overarching concern is that FDA appears to be proposing to publicly release sponsor data without prior authorization or agreement" from the trial's sponsor.

Itani said BSX sees non-summary outputs from pre-clinical studies and clinical trials as "trade secrets and commercial confidential information" because their disclosure would "provide our competitors with an unfair advantage" in developing similar products. She said BSX does not believe FDA is legally empowered to make such disclosures, adding that masked and de-identified safety and efficacy summaries "fall well within the definitions" of the terms "trade secret" and "confidential information."

Disclosure of these data may thwart efforts to obtain patent protection for prototype designs and procedures "in key markets," Itani continued, citing Europe and Canada specifically in this context. She asserted that non-clinical sponsor data could also compromise "test methods that are considered proprietary and unique to a particular technology," and that competitors could engage in reverse engineering of a device via such data with the help of "published scientific literature" on the device.

BSX's statutory argument proceeds from the six-year moratorium placed on FDA's internal use of such data, a feature of the Food and Drug Administration Modernization Act (FDAMA) of 1997, but Itani adds the point of FDA's own interpretation of FDAMA published in 2000. Itami states that the Aug. 9, 2000 guidance noted that the six-year provision for the agency's use of data does not give competitors "any new rights to see [an applicant's] data" despite that competitors may benefit by FDA's use of the data six years after the data in question arrived at FDA.

The Medical Imaging & Technology Alliance (MITA; Arlington, Virginia) filed an Aug. 5 statement for the docket, urging FDA to "ensure that this effort does not result in the release of proprietary information of any kind." The MITA letter recommends that FDA contact the sponsor for approval prior to the release of such information, adding that any procedures put in place for disclosure should ensure that the sponsor has 30 days notice prior to such disclosure.

FDA inks guidance for RF wireless devices

FDA released a final guidance dealing with radiofrequency communication in wireless medical devices, a long-awaited development given that the draft is dated 2008. The agency noted that the recommendations found in this guidance address devices that are "implanted, worn on the body, or other external wireless medical devices intended for use in hospitals, homes, clinics, clinical laboratories, and blood establishments."

The guidance states further that both wireless induction-based devices and radiated RF technology device systems "are within the scope" of the guidance, but that the use of RF energy to generate images of the body's internal structures, such as in MR systems, is not covered by the guidance document.

Medical Device Daily will cover the guidance in more detail in a future issue.

Aetna says 'aye' to MRI for organ prolapse

Aetna (Hartford, Connecticut) has declared in an Aug. 9 clinical policy bulletin that dynamic magnetic resonance imaging (MRI) is necessary in persons "with complex organ prolapse to supplement the physical examination."

The insurer noted in the same memo that Lefort colpocleisis is medically necessary for severe utero-vaginal prolapse in elderly patients and chronically ill persons who "no longer desire coital function." Aetna also declared that laparoscopic suture via rectopexy is likewise medically necessary for patients with rectal prolapse.

Among the citations of literature Aetna used in its analysis for the MRI memo was Barbaric et al in the 2001 volume of Topics in Magnetic Resonance Imaging, and Boyadzhan et al in the 2008 volume of Radiographics.

In an Aug. 13 bulletin, Aetna declared pyrophosphate muscle scan investigational when used in the evaluation of myalgia and myositis due to insufficient evidence in support of the procedure. The insurer also said nay to the Myoglobinuria test panel made by Athena Diagnostics (Worcester, Massachusetts) because it found no clinical evidence to support the use of the test, apparently in the test's use in diagnosis of myalgia and myositis.

Aetna's July 30 bulletin gave the nod to coil embolization in the treatment of splenic artery aneurysm, adding that endovascular embolization is "an acceptable treatment modality" for an extra-cranial arteriovenous malformation or fistula.

Among the other policies enunciated July 30 is that renal artery embolization/angio infarction is medically necessary "as a preoperative adjunct to nephrectomy" in treatment for patients diagnosed with large, hypervascular renal cell carcinomas. Transcatheter embolization is deemed medically necessary for treatment of intractable or recurrent severe posterior epistaxis only when conservative measures have failed.

Another procedure deemed medically necessary is tumor embolization (including preoperative embolization) when used to reduce intra-operative bleeding prior to surgical resection of hypervascular tumors or metastases from hypervascular tumors. Alcohol embolization or sclerotherapy and/or surgery is medically necessary for symptomatic venous malformations as evidenced by pain, swelling, ulceration, or hemorrhage, the insurer said.

Mark McCarty, 703-365-2519

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