PhRMA and GPhA Standing United Against Counterfeit Medicines at Interchange
John Castellani, President and Chief Executive Officer, Pharmaceutical Research and Manufacturers of America (PhRMA) and Ralph G. Neas, President and Chief Executive Officer, Generic Pharmaceutical Association (GPhA), took the dais together at the Partnership for Safe Medicines 2012 Interchange on September 28, 2012 to discuss the risks of counterfeits to patient safety.
At the 1:30pm panel, “Understanding Drug Safety & Security: Impact On Industry,” moderated by Scott LaGanga, Executive Director Partnership for Safe Medicines and Vice President, Public Affairs - Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA), LaGanga opened by saying, “The importance is that [Neas and Castellani] are sitting together for this kind of discussion. Clearly for the patient, it is not a reflection point of whether it is a brand or a generic but that it’s a product which for all intents and purposes is for their health and well-being.” LaGanga went on to point out that many studies have shown that the rogue online pharmacy community, operating outside of the law, serves as a clearing house for unapproved and dangerous counterfeits. Fortunately of the past several years, regulators, law-enforcement and industry have been improving efforts to combat them.
Castellani began by saying that while there is a perception that the branded and generic pharmaceutical makers disagree on many things, both groups are critically concerned about the impact of counterfeit medicines on patient health. “There is absolutely no daylight between the branded, patented medicines companies and the generic companies on the need to to protect patients and insuring the medicines they receive are genuine, approved, safe and effective.”
Castellani extolled the FDA’s oversight of medicine safety, “I want to remind patients that well over 99% of all medicines that are prescribed, that are manufactured, that are dispensed, and that are taken by patients are absolutely safe and they are safe and effective and genuine because of the very strong regulatory systems that we have in our country and around the world.”
Castellani went on to explain that pharmaceutical manufacturers and distributors have very strict standards to keep medicines safe. He’s most concerned with internet sites that pretend to be pharmacies, because of the ease with which websites can be created by counterfeit medicine sellers.
Ralph Neas continued by discussing that both the branded and generic manufacturing communities work collaboratively with the FDA to keep medicines safe. Said Neas, “You know that there are no differences with respect to safety, effectiveness and quality between generics and brands.” He went on to say that everything that is done for manufacturing for both generic and branded medications must comply with FDA regulations. He reminded the audience, “This is the safest drug supply in the world. But we know with respect to generics, especially on the internet, that there are some problems. And there are problems outside the US that we’re trying to address.”
Neas emphasized the FDA’s vital role in making sure the manufacturing world-wide is safe for patients.
He also highlighted the work of the Pharmaceutical Distribution Security Alliance, which is made of stakeholders in the supply chain from the manufacturers to the distributors and wholesalers, working to make sure that there is a national system to protect the security of our drug supply.
Neas agreed that manufacturers must work with law enforcement and regulators to work to protect patients from counterfeits on the internet.
LaGanga asked Castellani and Neas if they had concerns about counterfeit products within the regulated supply chain.
Said Castellani, “Without a strong belief by patients, physicians and clinicians everywhere that our medicines do what the FDA and we say that they are doing from a therapeutic standpoint then none of our system would be trusted.” Castellani continued by saying that all stakeholders involved in patient safety, from patient advocacy groups to doctors, have worked together to build a proposal for a national system to protect patient safety through a safe, secure drug supply.
Globally, pharmaceutical companies have banded together to work with INTERPOL to fight counterfeit drug sellers, kicking off in October. The program will help country-specific agencies align with INTERPOL’s international efforts, said Castellani.
LaGanga asked Neas about the generic manufacturer perspective on counterfeit medicines. Said Neas, “We want the entire world to have the benefit of the type of FDA system that we have in this country. And we have made a lot of progress and a lot of it has to do with the Partnership for Safe Medicines.”
Neas and Castellani co-wrote an opinion piece for Chain Drug Review that emphasized their shared concern for patient safety vulnerabilities due to counterfeit medication infiltration of the US.
Wrote Neads and Castellani, "At last week’s Partnership for Safe Medicines annual Interchange Conference in Washington, D.C., public health leaders from here and abroad explored broader global collaboration to keep patients safe from counterfeit or substandard medicines. While there is much more to be done, the international community is demonstrating its commitment to sharing information on counterfeiters, enacting effective standards and reviews, and limiting the opportunity for counterfeit drugs to get into the global pipeline.
"Both the research-based biopharmaceutical and generics industries are collaborating with U.S. and foreign regulators and law enforcement agencies to seek new areas of cooperation. Maintaining the public’s confidence in the integrity and safety of our products is of paramount importance; eradicating the counterfeit drug trade is a top priority."
Their panel at the Interchange is available in the Interchange archive.
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