Even the most ardent advocate for globalization would have a hard time defending our utter dependence on foreign imports for critical supply chain items, such as food, energy, infrastructure and, increasingly, medicine. To do so blindly, dogmatically, without a countervailing commitment to domestic production, even as a mere contingency, is a self-imposed strategic blunder. And we’re living with the repercussions right now.
Now, proposed amendments to the Prescription Drug User Fee Act aim to further amplify the risks of our pharmaceutical supply chain by doubling down on foreign dependence and loosening the safety requirements for imported drugs. Without proper safety regulation priced in, these drugs and active pharmaceutical ingredients will be cheaper, certainly, but at the cost of stifled incentive for domestic innovation, increased risk of deadly counterfeit drugs and further threats to supply chain diversity, integrity and national security.
The FDA’s Prescription Drug User Fee Act—or PDUFA—was enacted in 1992 with the goal of accelerating the process of getting safe and effective drugs to American patients (the key words being “safe and effective”). It has dramatically improved the speed of approvals and delivery of safe medications and therapies to the citizens of the United States by improving the funding and reach of appropriate regulation. Therefore, it has been reauthorized continually, typically without substantive amendment.
So the question becomes: Why amend the law now in such a manner as to loosen the very tenets it was founded upon? We’re already vulnerable enough—88% of active pharmaceutical ingredient manufacturing sites and 63% of finished drug products demanded by the U.S. market are manufactured outside the United States. Likewise, greater than 80% of active pharmaceutical ingredients for essential medicines have no U.S.-based manufacturing. So why even entertain an amendment that further tilts the global playing field toward less oversight and more price advantage?
Truly, this will only stifle the incentive to innovate and create our own domestic manufacturing. With an eye toward our increasingly aggressive, near-peer geopolitical adversaries, might we instead focus on motivating U.S.-based manufacturing of precursor materials and finished drug products to balance the global playing field and reward or invest in domestic capability?
Likewise, how can we be sure the drugs we’re taking are safe and effective if we are limiting safety, oversight and evaluation of medicines being manufactured in foreign countries with weaker safety standards? In recent years, the FDA has been working to increase its overseas presence to better monitor conditions at foreign drug manufacturing facilities. But as FDA Commissioner Scott Gottlieb noted in a statement, “It would be naïve to think that our inspectors are everywhere they need to be, all the time.” This is particularly true given the FDA’s limited resources and the vastness of the global pharmaceutical supply chain.
Now imagine the increased potential for counterfeit drugs to disrupt lives and complicate the delivery of health care after we further loosen our already strained oversight within an increasingly complex supply chain. Imagine prioritizing policies of globalization and supply chain dependence over the lives of our citizens and over safe, domestically produced, innovative, supply chain solutions for pharmaceuticals and active ingredients. That’s what a vote for the proposed amendments to PDUFA package would support.
PDUFA works. We should reauthorize it and reject amended packages that amplify domestic vulnerability and focus our attention on investing in domestic capability. We cannot afford to be reliant on imported drugs, especially when far too many risks are involved. We must diversify our supply chain and make a commitment to domestic production if we want to ensure access to safe and effective medicines for all Americans.•
Hungate is director of wellness and employer strategy at Hancock Regional Hospital.