Medical Device Daily Washington Editor

Makers of combination products may at times feel as though they risk a regulatory form of double jeopardy where good manufacturing practices (GMPs) are concerned, and FDA seemed to have taken its eye off this target for several years after its 2004 draft guidance on the topic.

The agency finally published a proposed final guidance in the Federal Register last week that establishes a superset of sorts of the regulatory schemes for the component parts of a combination product, although the details might not come as too big a surprise to any stakeholders who have routinely engaged FDA in a dialogue on the topic.

According to FDA, it had received only 15 comments after publishing the 2004 draft, although the agency states that most of those comments "were largely supportive of the regulatory approach" embodied in the draft. FDA also notes in the FR notice that a common theme "that emerged ... was the need to develop a clear regulatory framework" that sidesteps unnecessary redundancy. "Hence, FDA proposes to create 21 CFR Part 4, subpart A" to deal with GMPs, although a subpart B for post-market requirements is still in the works.

Essentially, a GMP system dealing with a drug/device combination that fully complies with the GMPs for drugs under 21 CFR Parts 210 and 211 would have to clear six elements of the Quality Systems Regulations (QSRs) under 21 CFR Part 820. These include subsection 20 (management responsibility), subsection 30 (design controls), and subsection 50 (purchasing controls). The other three elements, subsections 100, 170 and 200, address corrective and preventive action, device installation, and servicing, respectively.

Conversely a drug/device combination product made in a facility demonstrated to comply with the QSRs would have to demonstrate compliance with eight elements of drug GMPs. Among these is part 211 subsection 84, which governs testing of components, drug closures and containers. Other subsections in this list are those dealing with calculations of yields, stability determinations, and expiration dating.

And of interest to makers of biologics, the FR notice indicates that any combination products that involve human cells, tissues, and cellular and tissue-based products that had been regulated under section 361 of the Public Health Service Act would become a biologic under 21 CFR parts 210 and 211, which are the drug GMP requirements, as well as part 1271, the portion of the code that addresses human tissues and products derived from them. Section 361 deals with authorities granted to the Secretary of Health and Human Services to deal with outbreaks of communicable diseases, presumably making this a reference to vaccines.

This so-called streamlined approach can be applied to a single facility making all the constituent parts of a combination product, but the picture muddies when more than one facility is involved. If the combination product employs a drug made at one plant and a device made at another, each facility must, of course, maintain its specific GMP standards while the facility at which the two are combined can employ the streamlined approach.

If both components are made in the same facility but sent to a second plant for assembly, the streamlined approach "could be used ... in both facilities," FDA notes. Inspections, would of course, be geared to align with the appropriate GMP rubric.

Senators object to Medicare imaging cuts

A recent payment proposal by the Centers for Medicare & Medicaid Services that would peg the presumed utilization rate for outpatient imaging clinics at 90% has drawn fire from Capitol Hill in the form of a letter from a bipartisan group of senators who are concerned about the impact on radiological treatment for cancer.

The move by CMS to reimburse freestanding radiology clinics based on a presumption that their machines that cost $1 million or more typically stay busy 90% of their hours of operation would force some cancer clinics to cease operations, according to Senators Blanche Lincoln (D-Arkansas) and Richard Burr (R-North Carolina). The senators also wrote that the 90% set point "is particularly troubling" because of survey data suggesting "that radiation oncology practice expenses have remained relatively stable or experienced modest increases over time." The senators suggested CMS "consider recalibrating specialty reimbursement to support primary care in a way that does not place a disproportionate burden on any one specialty provider group."

The American Society for Radiation Oncology (ASTRO: Fairfax, Virginia) weighed in on the issue at the beginning of September with a letter urging CMS to reconsider the move based on a calculation that the overall reduction in payments of 19% would shave 44% off the number of anti-cancer sessions performed under Medicare.

The 90% set point was discussed earlier this year at a meeting of the Medicare Payment Advisory Commission (Medical Device Daily, March 18, 2009), an approach picked up by CMS as evidenced in its proposed fee schedule for physicians under Part B in July (MDD, July 6, 2009).

Finance Committee avoids public option

The Senate Finance Committee, the last of the five congressional committees to complete a healthcare reform bill, opted to leave a public option out of its mark-up of the legislation in a meeting held Tuesday.

Baucus said during the hearing his job "is to put together a bill that gets 60 votes," and that "no one has been able to show me how we can get to 60 votes with a public option in the bill." Baucus's comment implicitly addressed the failure of a proposed amendment by Sen. Jay Rockefeller (D-West Virginia) that would have introduced a public health insurance option into the legislation.

Rockefeller's amendment drew unanimous opposition on mark-up from Republicans, but also lost four Democrats in addition to Baucus, including Kent Conrad (North Dakota), the chair of the Senate Budget Committee. Also voting against the public option were Democrats Bill Nelson (Florida), Tom Carper (Delaware), and Blanche Lincoln (Arkansas).

The Senate Finance Committee has been the focus of perhaps more controversy in the healthcare legislation debate, certainly where public health activists are concerned as demonstrated by hearings held by the committee earlier this year in which protesters decried the lack of representation for a single-payer system on a panel of witnesses (MDD, May 6, 2009). Baucus has gone on record as saying that the U.S. might never adopt a single-payer system, but the Finance Committee bill will most likely have to be reconciled with the bill produced by the Senate Health, Education, Labor and Pensions Committee for presentation to the Senate. The HELP Committee bill includes the public option.

Mark McCarty, 703-268-5690;