The Food and Drug Administration Nov. 13 issued a request asking manufacturers to voluntarily change packaging and labeling for some over the counter topical antiseptic products, including single-use pads, wipes and swabs. The announcement, part of the agency’s ongoing evaluation of these products, comes nearly a year after it had convened a public hearing and solicited stakeholder comments to examine concerns about microbial contamination of antiseptic patient preoperative skin preparation products following several reports of infection outbreaks and related product recalls. Since that time, the FDA has been looking at a range of issues related to intrinsic and extrinsic contamination, with one of the primary questions being whether these products should be required to be manufactured sterile.
The Nov. 13 request is directed at solutions, swabs, pads saturated with a solution, and applicators containing solutions typically including isopropyl or ethyl alcohol, povidone iodine, poloxamer-iodine, benzalkonium chloride, benzethonium chloride, or chlorhexidine gluconate as a single agent or in combination with alcohol. These products, frequently made with nonwoven fabrics, are used for preoperative or preinjection skin preparation, in hospital and clinical settings, as well as sold over the counter. Although the products are designed to prevent pathogens from entering the body, they can sometimes become contaminated with the very infection-causing microbes they are designed to protect against.
The most recent FDA notice calls on manufacturers to package antiseptics indicated for preoperative or preinjection skin preparation in single-use containers and for labels to indicate whether the antiseptic is manufactured as a sterile or nonsterile product. The FDA also advised that antiseptics in single-use containers be applied only one time to one patient, that health care professionals and patients not dilute antiseptic products after opening them, and that applicators and unused solution be discarded after the single application. As for the label changes, the FDA believes indicating whether the product was manufactured under sterile conditions or not will assist health care professionals in making informed decisions about using these products.
In a hearing notice and request for comments published Nov. 21, 2012, FDA said it was interested in better understanding how bacteria can contaminate preoperative skin preparations during manufacturing (intrinsic contamination) and during product use (extrinsic contamination). The FDA sought recommendations to minimize these instances, including input on whether sterile manufacturing should be required rather than only requiring that current good manufacturing practices (CGMP) be followed.
In presentations and written submissions, INDA and other industry stakeholders argued that sterile manufacturing requirements would not address extrinsic contamination because of how and where the products are used and also urged FDA to provide more guidance on CGMPs to reduce instances of intrinsic contamination. All warned that a greater risk of infection would result from a lack of access to the products due to shortages and high prices and stressed there was not sufficient evidence of harm to justify such a drastic change in manufacturing requirements. The industry groups agreed that better education of proper use by consumers and health care providers, and more single use products, checklists, and expiration dates on multi-use products could lead to fewer incidents of contamination.
The FDA appears to have heeded the industry input and has taken an incremental approach by asking manufacturers to implement voluntary changes and also offered guidance on ways to reduce extrinsic contamination. The FDA has said it will continue to evaluate this safety issue and will take additional actions as needed.
For more information, visit www.fda.gov/Drugs/DrugSafety/ucm374711.htm.
Congress Expected to Take Action on MTB
Insiders expect that if Congress passes the Miscellaneous Tariff Bill (MTB), it will most likely be in early January as part of a larger push of legislation addressing multiple trade issues. The U.S. House of Representatives recessed Dec. 12 without taking further action on the omnibus Miscellaneous Tariff Bill (H.R. 2708) that had been introduced by the chamber’s Ways and Means Committee in July. Congress also failed to move legislation reauthorizing the Generalized System of Preferences (GSP) and reinstating Trade Promotion Authority (TPA). All three of these bills are regarded as vital in advancing free and fair trade for manufacturers.
The MTB provides critical import duty relief on hundreds of essential manufacturing inputs that are not available in the U.S., including viscose rayon staple fibers. Unfortunately, Congress allowed the duty relief benefits to lapse at the end of 2012, forcing U.S. companies to absorb the additional costs throughout the year and affecting their ability to compete. H.R. 2708, the stalled bill that reinstates MTB relief, includes several provisions covering rayon staple fibers but does not provide for a retroactive refund of tariffs. There is no corresponding MTB measure before the Senate, which has been distracted while some lawmakers debate whether the duty relief constitutes an earmark and still others have introduced bills to revise the MTB process altogether.
Meanwhile, despite the fact that bi-partisan legislation that would have renewed the GSP was introduced in the House over the summer, lawmakers allowed that program to expire on July 31. Originally enacted in 1976, GSP is a U.S. trade program designed to promote economic growth in the developing world by providing preferential duty-free entry for approximately 4,800 products from over 100 designated beneficiary countries and territories. Manufacturing groups generally support the extension of GSP, which provides preferential access to certain imports including raw materials, components, parts, or other inputs used to manufacture goods here in the United States. GSP reduces input costs, making products more competitive with global counterparts.
Bills to renew the GSP program are pending in both chambers of Congress. H.R. 2709 provided for renewal of the program until September 30, 2015 without substantive changes. The related Senate bill (S. 1331) introduced July 18, however, called for specific funding offsets. Unfortunately, due to the disagreement over the offsets no further action has been taken on either bill. In the past, Congress has passed bills renewing the GSP after it has expired and provided for the refund of tariffs, so supporters are hopeful that will be the case this time as well.
TPA, which expired in 2007, is another important trade law that Congress has neglected during the most recent session. The Obama administration has long called for Congress to reinstate TPA, which is also called fast track negotiating authority. Under TPA, trade agreements would move swiftly through Congress allowing lawmakers only to vote yea or nay, but not to amend or filibuster the deals. The Obama administration views TPA as essential to finalizing significant trade deals, specifically the Trans-Pacific Partnership (TPP) and the Transatlantic Trade and Investment Partnership (T-TIP).