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| Janet Woodcock |
The quality of manufacturing at a state-of-the-art plant is going to be better than at one that is old, out of date and not maintained. But there is really no way for patients and their doctors to pick the product made at the better facility. And so the FDA's top quality regulator thinks it might be time to put letter grades on manufactured products in hopes of leading drugmakers to invest more, particularly in complex sterile manufacturing facilities.
"It would then be up to the marketplace to answer the ultimate question: How much are we willing to pay for quality?" Janet Woodcock, director of the Center for Drug Evaluation Research (CDER), said in a paper she authored with Marta Wosinska, director of economics staff at CDER, that appears in Clinical Pharmacology & Therapeutics.
The economics of sterile drug manufacturing has kept some drugmakers from putting much into old plants which make, generic, low-margin drugs that still require high levels of sterility and are essential to healthcare. When those plants are found to be lacking, then the FDA has decide whether to push to shut them down to protect consumers or leave them open while they address issues because they manufacture products no one else does. Resulting drug shortages have been a huge problem for patients and the agency.
"Not every production disruption turns into a shortage, but virtually all shortages are preceded by disruptions in production," the paper points out. And as Regulatory Focus reports, consumers have no way of knowing which products come from the best plants. They buy on price or doctor recommendations.
And so the duo say, "we have now reached a point where FDA needs to engage the marketplace to help address the manufacturing problems, which unilateral FDA actions have not been able to prevent.
"FDA could support the buyers and payers in their purchase and reimbursement decisions by providing them with meaningful manufacturing quality metrics." It has worked in other settings where quality can be tough to figure out, like HMOs and yes, the local diner. "Restaurant grades, HMO scorecards or even a U.S. Pharmacopeia stamp on vitamins are just a few among many tools that utilize this concept."
- here's the report (pdf)
- get more from Regulatory Focus