Another viewpoint: Drug-making innovations need regulatory support, incentives

Bloomberg Opinion

One 800-square-foot laboratory at Rutgers University in central New Jersey is equipped to make more than 1 billion prescription pills a year.

Its manufacturing process is faster, cheaper and more precise than traditional methods, potentially reducing reliance on factories abroad.

The technology also can be used to make drugs currently in shortage, including cancer treatments. Why them isn’t this major manufacturing innovation more widespread?

Most drugs are made using batch manufacturing, a laborious, multistep process that stretches across continents. Storage and shipping between stages can compromise quality. Reliance on overseas manufacturers, meanwhile, is risky. About 80% of key drug ingredients are made outside the U.S., predominantly in China and India, where U.S. regulators have uncovered serious breaches of manufacturing standards. Should China cut off pharmaceutical exports, as some policymakers have warned, the domestic stockpile of lifesaving medication would run out in a matter of weeks.

Advanced manufacturing processes can help. One method, known as continuous manufacturing, can develop a new drug product in weeks — something that would take months by batch processes — all in a single facility. The basic technology has been used for decades in other industries. Applied to pharma, it could have pronounced benefits.

Some of the world’s largest drugmakers are among the earliest adopters, including Pfizer Inc., Eli Lilly & Co. and GSK Plc. Other companies exploring advanced techniques include the Mark Cuban Cost Plus Drug Company, whose Texas facility can pivot from one drug type to another in a matter of hours, according to recent testimony to Congress by its chief executive officer.

The Food and Drug Administration could take more action to earn the industry’s trust. The agency supports continuous manufacturing and generally approves such processes more quickly than the traditional kind. Yet drugmakers still cite the prospect of costly delays as a chief deterrent.

The FDA should accelerate the application process by eliminating duplicative reviews for minor changes and establishing site-based, rather than product-by-product, approvals for advanced facilities.

It should also reduce inefficiencies during the review process and better align with global regulators on approvals. Such measures would go a long way toward gaining the buy-in of senior management, which tends to prioritize research and development over manufacturing investment.

Congress should revive a bill to establish so-called centers of excellence, like the one at Rutgers, nationwide. In addition to training workers and conducting basic research, such institutions would give manufacturers of generics and smaller branded drugs access to expertise and production capabilities unavailable in-house. Allowing companies to deduct R&D costs immediately — a once-standard practice that Congress has now inadvertently outlawed — would also boost innovation and investment in the field.

Continuous manufacturing could revolutionize the industry. Policymakers should ensure they aren’t standing in the way of progress.