Suppliers to medical device manufacturers fear the long arm of the FDA may push up prices of medical devices while reducing the products' availability and quality. The costs of medical devices almost surely will skyrocket, plastics processors and compounders say, if they are forced to meet the same federal manufacturing rules as producers of the final product. That was the testimony of the Food and Drug Administration before an independent panel Sept. 13 in Gaithersburg, Md.
Upstream suppliers of medical device manufacturers are concerned the FDA might extend good manufacturing practice requirements - currently applying only to the actual producers of a final product - to them.
Currently, the agency is recommending against the further inclusion of suppliers, and presented its case to exempt them from the good manufacturing practice guidelines to the special GMP panel meeting here last week. The panel will review the recommendations through the end of October, when it is expected to issue an opinion.
The recommendations mark a reversal from an FDA policy forwarded two years ago and not yet approved. In the interest of assuring quality in medical devices, the FDA had sought to bring all aspects of the production of medical devices under the GMP umbrella and presented recommendations to include their components as well.
But now, said Julius Rakus, manager of regulatory compliance for vinyl compounder AlphaGary Inc. in Newark, N.J., the agency has recommended a reversal of that proposal. Now, Rakus said, the advisory committee will have to determine if the FDA's reasoning for reversing its position since the initial proposal is sound.
Rakus and the Health Industry Manufacturers Association contend the high cost of meeting GMP standards, instead, might serve to push good suppliers out of the field and ``would not add to the performance of our niche.'' He cited this as a primary reason for supporting the latest FDA recommendations.
HIMA's testimony before the GMP advisory committee noted the original proposal ``simply provides the FDA another means for addressing another party in the event of a systematic device failure.''
The modification of FDA's recommendation is important to all in the medical device industry, more than ever sensitive to their legal liability if a device malfunctions and worried that supply lines may dry up.
Legislation directly reducing liability of upstream suppliers is stalled in Congress.
Both houses have passed product liability legislation, but SPI counsel Jerry Heckman said no House-Senate conference committee to reconcile the bills' differences has been named and the legislation ``may go nowhere this session.''
Rakus said the addition of GMP requirements would be difficult, but not impossible, for suppliers.
Hardest hit would be producers of internal lubricants, colorants and slip agents used in vinyl compounds, Rakus said.
Supplier inclusion in the FDA GMP rules ``would significantly increase the cost of medical devices without improving the quality of the product,'' he said.
Further, Rakus said he is worried that imposition of GMP rules down the line might mean ``medical device manufacturers could look to satisfy FDA rather than their own stringent requirements.''
The bulk of business at AlphaGary's Newark branch produces vinyl compounds for use in many medical disposables. According to Rakus, the Newark operation is one of fewer than a dozen involved in medical device compounding. AlphaGary, formed two years ago with the merger of Alpha Chemical and Plastics Corp., Pineville, N.C., and Gary Corp., Leominster, Mass., also manufacturers thermoplastic elastomer compounds and wire and cable compounds. It is owned by the British Laporte plc.
The Society of the Plastics Industry Inc. in Washington op-poses including suppliers under GMP standards. Mark Sievers, a lawyer with the Washington law firm of Keller and Heckman, testified Aug. 23 at a hearing at FDA's Center for Devices and Radiological Health that applying GMPs to components is ``over broad and unnecessary.
``The term `component' as defined in the [FDA] working draft [of GMP applications] encompasses virtually any plastic article intended by the device manufacturer to be included in the finished device as packaged and labeled,'' his testimony noted.
Removing components from the GMP chain is ``definitely a benefit for suppliers, but they're still supposed to be acquainted with the GMP guidelines for manufacturers,'' Sievers said in an interview last week. ``The benefit is that manufactures have the opportunity to work with suppliers, giving them more flexibility to work with one another and not follow the full range of GMPs,'' he said.
``The closer you are to the finished device, the more will be expected of you in terms of quality control,'' he said.
