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Purchasers beware

Better oversight of foreign pharma plants just the first step

 

By Mike Alkire
In 2008, the Food and Drug Administration estimates that as many as 146 patients died in the U.S. after receiving heparin manufactured using counterfeit raw materials in China. The contaminated heparin contained oversulfated chondroitin sulfate, which costs $9 a pound compared with $900 a pound for heparin.

Sadly, this is not an isolated incident. The World Health Organization says up to 10% of the world's medicines are fakes; in China and India, that's true for up to a third of medicines sold. Even so, U.S. drug companies purchase 40% of their active pharmaceutical ingredients, or API, from the counterfeiting hotbeds of India and China – with some estimating this may reach 80% within 15 years.

Chinese authorities are weak enforcers of drug regulations, mostly because corruption and bribery have allowed counterfeiters to thrive. Moreover, the Chinese government has a record of obscuring health scandals to avoid embarrassment. In the case of API, the Chinese say that they aren't responsible for ingredients used outside the country, so they aren't regulated. The problem isn't better in India, where there is no drug regulatory agency.

Although the U.S. Food and Drug Administration is supposed to conduct regular inspections of overseas facilities, the agency has just eight inspectors for all device and pharmaceutical manufacturing in China. Considering the volume of overseas production, these facilities may get inspected every 13 years compared with every 2.7 years in America.

Meanwhile, the FDA does not even have a comprehensive list of foreign API suppliers, so there may be more facilities that have never been inspected. I hope a reinvigorated FDA under Margaret Hamburg and a new Congress with a stated commitment to drug safety will do more.

We need government action to ensure rigorous oversight of the supply chain – from chemicals to finished products. Leading experts agree that U.S. authorities can't be everywhere, so some of the responsibility for registering and inspecting facilities must be led by foreign regulators. In most nations, oversight can be trusted. In nations like China and India, regulators must get serious about preventing counterfeiting, and U.S. trade authorities must work to ensure adequate oversight is in place.

Second, the U.S. government needs to pressure foreign nations to regulate API the same way they do finished pharmaceuticals, and ensure those laws are enforced.

Lastly, criminal penalties for counterfeiting must be strengthened. Even in the U.S., counterfeiting a drug label is punishable by up to 10 years in prison, while counterfeiting the drug gets only three years. To fix the problem, we need the same enforcement and interagency coordination that we devote to other global organized crimes. These increased penalties need to be included as part of trade agreements and enforced via cooperative coordination among law enforcement.

Knowing the challenges of regulating API from regions with poor safety records, manufacturers should exert more control by requiring that suppliers meet distribution and safety standards. Manufacturers can reduce risks by obtaining intelligence about the distribution chains for imports, establishing procedures to qualify suppliers and ensuring the purity of ingredients.

Manufacturers should inspect suppliers rigorously and repeatedly and have a traceable supply chain to identify raw materials to the lot level. Each lot should be inspected by quality control to ensure purity, in compliance with good manufacturing practices. Suppliers should provide audits and drug master files as evidence that materials are from safe sources.

Manufacturers have most of these measures in place today, but compliance abroad is inconsistent. Manufacturers may want to revisit their policies and do further due diligence to address new safety threats. In every case, manufacturers sourcing abroad must be vigilant and design quality controls that set the highest bar for safety.

For purchasers, protecting patients requires factoring in safety before buying. Do you know where the pharmaceuticals in your facility are made? Does the manufacturer have in place adequate controls to ensure the safety of their API? These are not questions typically asked, but the risk of not knowing could mean putting lives in jeopardy.

One way for hospitals to get answers on safety is to assign the task to their group purchasing organization. GPOs develop contract terms with hundreds of manufacturers, and can insist on transparency – that drug manufacturers disclose where the medicine was made, the safety and quality measures in place and whether additional steps have been taken, such as working with an accreditation or third-party auditor to ensure safety.

Armed with this information, hospitals can choose products based on the protections in place, and take significant steps to improve safety while creating a competitive incentive for manufacturers to continually enhance safety protocols.

According to former FDA associate commissioner Peter Pitts, pharmaceutical counterfeiters are committing nothing short of healthcare terrorism. There are serious risks affecting patients, and we have a moral imperative to ensure safety and punish those who would put lives in jeopardy. We all have a role to play and a responsibility to get it right. Anything short of that is unacceptable.