A Medical Device Daily

The federal government's draft import action plan has been in the works for some time, but industry has wondered exactly what sort of standards Uncle Sam might require of makers of food, drugs and devices. Industry need wonder no more as FDA and other agencies and departments have added to the federal alphabet soup with the publication of a draft guidance on good importer practices, or GIPs.

The document says that importers should develop a product safety management program, which would include "a clear management structure for product safety," not unlike the management review requirements of the quality systems regulations for devices. Responsibility for compliance should be delegated "to specific individuals" who possess "the necessary training, knowledge, experience, skills and competence," the guidance states. Importing firms will also have to "maintain records to demonstrate how compliance with requirements was achieved." Risk evaluations would also be a part of the product safety management program.

Another general requirement would be familiarity with the "risks and compliance history" of the product and the entity that makes the product. A third requirement is tracking the product through the product's life cycle, which may boost the prospects of companies that offer radio-frequency identification technologies. On the other hand, the guidance also suggests that the importer or a third party "conduct paper audits" of overseas manufacturing entities.

Corrective and preventive action (CAPA), as might be expected, is among the elements in the plan. The document says that such activities be spelled out, including procedures for "disposal/destruction or export of non-compliant products," as well as a root-cause analyses for failing products. Importers who end up with problems should "work with the non-compliant firm to meet U.S. requirements or stop conducting business with the firm."

NIH releases technologies for licensing

The National Institutes of Health has published a notice in the Federal Register regarding technologies it will license to industry, and the list is heavily populated with diagnostics. Makers of imaging equipment might be especially interested in several of the offerings.

According to the Feb. 23 edition of the FR, NIH is willing to license a new real-time polymerase chain reaction array "that allows for simultaneous transcriptional profiling of the human herpesvirus HHV6A genome," a tool that could be used to determine the "contribution of HHV6A to the development" of lymphomas and other cancers when an infectious agent is suspected.

Another item of interest this one to makers of imaging equipment is a patent for an electron paramagnetic resonance (EPR) "image formation strategy for in vivo imaging of physiological functions." According to the notice, single-point imaging with EPR can track tissue oxygenation to help plan radiation and chemotherapy doses. This approach to tissue imaging is said to offer the high contrast found in spin-echo Fourier imaging along with the "super-high resolution" of the single-point methodology, which offers "reliable EPR imaging for tissue physiological function in vivo."

NIH is also making available a technique for navigation of the large intestine that allows more precise registration of polyps by using the locations of bands of muscle in the colon as grids. The teniae coli are described as "three equal-distanced bands of longitudinal smooth muscle on the surface of the colon," which can be used as reference points to assist in coordinating images drawn from the patient in face-down and face-up positions. The document does not state how much of an improvement the teniae coli reference system is over other mapping approaches, but states that the technology "allows for more detailed detection of anatomical features for surgical planning, better camera orientation" and "more efficient lesion registration."

Not to be left out, makers of vaccines may want to look into a technology that "relates to compositions and methods for improving the growth characteristics of cells engineered to produce live viruses."

NIH researchers have come up with a means by which vaccine makers can convert Madin-Darby canine kidney cells "into a suspension culture" which provides an alternative to chicken eggs as a medium for virus production. According to the FR notice, the technology can "improve yields and reduce the cost" thanks to the insertion of an unspecified human gene, which apparently has the effect of improving growth and adhesion characteristics as well as cell density growth and hemagluttin production.

Specter reintroduces client privilege bill

The issue of attorney-client privilege has cropped up repeatedly since 1999, with memos by the Department of Justice (DoJ) seeming to roll forward and back on the issue of the behavior of federal prosecutors. Despite reassuring comments by Eric Holder, the new attorney general, Sen. Arlen Specter (R-Pennsylvania) has reintroduced the Attorney-Client Protection Act (S. 445) to the 111th Congress to deal with pressure applied by prosecutors aimed at obtaining access to documents that ordinarily are covered by privilege.

According to a Feb. 20 story in the National Law Journal, a new set of standards published last year, known as the Filip guidelines, were purported to have disallowed the prosecutorial practice of requiring that firms waive privilege in order to gain "credit" for having cooperated with an investigation. However, Specter is said to be unmollified by Holder's promise to abide by the Filip guidelines, which largely roll back several of the more controversial elements of the Thompson memo of 2003.

According to the NLJ article, Specter, the ranking member of the Senate Judiciary Committee, said on the Senate floor earlier this month that while the Filip guidelines, named after deputy attorney general Mark Filip, for the most part do not allow a prosecutor to ask for waivers, "the Filip reforms cannot be trusted to remain static" given DoJ's history of issuing "numerous versions of ... corporate prosecution guidelines over the past decade."

Specter is also said to have argued that "legislation is necessary," given that the Filip guidelines would be "subject to unilateral executive branch modification." According to NLJ, Specter's bill would also forbid federal prosecutors from prosecuting corporations more or less leniently based on whether companies deny legal fee payments for company executives.

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