Mustering Support for Import Safety
Private industry and public regulators are taking exceptional steps to protect the security of the healthcare supply chain. Pharmaceutical companies have rolled out anticounterfeiting technologies and tightened supply chains to enable fuller control and visibility of product shipments.
In the area of regulation, multiple federal agencies are collaborating in the Interagency Working Group On Import Safety to establish oversight on imported product that reaches across global borders.
As security measures are adopted and regulatory bodies take action, new incidences of tainted or counterfeit product drive home the scope of the problem and the need for the heightened vigilance.
The Netherlands Health Care Inspectorate last month issued a public warning after the discovery of 2 million counterfeit insulin syringe needles distributed into the Dutch market and the United Kingdom.
The counterfeit product came to light after Novo Nordisk, the manufacturer and distributor of NovoFine insulin needles, received a customer complaint that a recently purchased needle didn’t fit properly onto the insulin-delivery pen.
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The Partnership For Safe Medicines reports on its Web site (www.safemedicines.org) that 30,000 of 200,000 counterfeit needles introduced into the Netherlands remain unaccounted for. A Dutch company had purchased 2000 packs of needles from a wholesaler in Malaysia that claimed the needles came from Iran, the Web site reports.
Besides being of inferior quality, the counterfeit needles showed packaging information in English, while the information is printed in Dutch on genuine needles distributed in the Netherlands. The packing has no bar code, is missing a line below a “CE” logo, and may feature traces of transparent adhesive where the needle is fixed to the plastic holder, officials announced.
New draft legislation has been introduced in the U.S. House of Representatives to establish requirements for imported products, increase inspections of foreign facilities by FDA, and provide funding for agency oversight and enforcement.
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FINE TUNING REGULATION
House bill HR 2749 in a draft version has been released as a replacement to the FDA Globalization Act, first launched in 2008 as a measure to address issues posed by substandard food and drug imports.
Though HR 2749—the Food Safety Enhancement Act of 2009—focuses primarily on food safety, it includes “miscellaneous” provisions on the regulation of imported drugs, biologics, and medical devices.
Sponsors including Energy and Commerce committee chairman Henry Waxman and Rep. John Dingell plan to issue separate additional legislation on drugs and devices at a later date, reports Rx-360, the consortium organization for pharmaceutical supply-chain issues (www.rx-360.org).
HR 2749 includes requirements pertaining to drugs and devices that mirror provisions of the original Globalization Act, including the assessment of annual registration fees on importers, and the establishment
by FDA of a dedicated corps of inspectors for inspection of foreign facilities.
Other provisions as well are similar to the previous act’s requirements. Registering importers have to provide unique identifiers for facilities and importers and comply with good importer practices that include verification of good manufacturing practices and preventive controls of the importer’s foreign suppliers. The secretary of the Department of Health and Human Services (HHS) is authorized to enter into cooperative agreements with foreign officials to ensure compliant practices. The bill includes protection for whistle blowers.
In seeking to guarantee funding to FDA for import enforcement, the Globalization Act, as originally presented, called for parity between foreign and domestic facility inspections, country of origin labeling, the prohibited entry of drugs into the United States without safety documentation, and requirements for manufacturers to ensure the safety of their supply chains.
A coordinated program that includes HHS/FDA, the Consumer Product Safety Commission, the Department of Transportation, and the Department of Homeland Security, the InterAgency Working Group On Import Safety represents what HHS has called a fundamental, government-wide shift to increase international collaboration for enhancing food and medical product safety. Moving beyond U.S. borders, the agencies will work with trading partners to ensure product life cycle quality by targeting areas where the risk is highest.
An InterAgency Import Safety Action Plan was launched last year with an FDA pilot project with counterparts in the EU and Australia for inspecting drug manufacturing facilities.
FDA’s Beyond Our Borders initiative has advanced with the opening of an office in Costa Rica, the first of several planned for serving Central and South America and Mexico. FDA offices supporting regulatory collaboration have opened in Brussels and in Beijing, Shanghai, and Guangzhou, China.
In its recently released “Good Importer Practices” draft guidance, FDA emphasizes supply-chain compliance with U.S. requirements. For support of domestic and foreign supply-chain oversight, the agency is seeking legislative authority to accredit third-party organizations such as other federal agencies, foreign agencies, and state and local entities for evaluating compliance with FDA standards.
The guidance advises that importing companies should establish a product safety management program that would include the evaluation of supply-chain vulnerabilities and the setting up of preventive controls.
Pharma firms have focused on streamlining supply chains to enhance control and visibility, promote security, and comply with FDA supply-chain requirements.
In consolidating consignments with fewer transport firms and third-party logistics providers (3PLs), shippers have sought to reduce the supply-chain “touches” that invite transportation delays and may leave
product and packaging vulnerable to tampering.
LifeScience Logistics (Dallas) imports finished pharmaceutical product and bulk APIs for several clients, mostly from European-based facilities.
Manufacturers are expressing increased concerns in the areas of security and temperature monitoring and control, says Richard Beeny, CEO. “We have seen increased emphasis on the integrated carriers, such as FedEx and UPS and their specialty services,” he says. “Customers don’t want to use a common carrier where they have less control over shipment legs, and where product might get bumped at distribution points and delayed.”
“We have done a lot of work with FedEx Custom Critical where we will develop dedicated routes that bypass the high-traffic hubs,” Beeny says.
As a 3PL, LifeScience Logistics consults on carrier selection, routing, packaging, SOPs, and how product will be delivered, received, and inspected.
“We can help our clients manage risk with specialized SOPs for how product is handled on the tarmac, when it is unloaded, and where it is stored before the next flight,” Beeney says. ■