Government wants to grade drugmakers, but keep grades secret
Federal regulators want to grade drug companies on the manufacturing quality of their product or factory, but don’t want to share that grade with the public.
Patients have become more empowered in their healthcare decisions, using websites like Yelp to determine the quality of a doctor or hospital. There are some tools for evaluating the quality of a drug maker. The Food and Drug Administration posts warnings to companies for egregious offenses and some inspection reports of facilities on its website.
But agency officials have said there isn’t a good picture of quality of pharmaceutical manufacturing as a whole, let alone where an individual drug maker fits in that picture.
The agency hopes to change that by implementing its quality metrics program.
The goal of the program is to help the FDA sort out the high-quality manufacturers from the poor quality ones. By doing so, the agency would be able to inspect the low-quality manufacturers more than the ones that don’t need as much oversight.
In July, the agency announced it intends to require four types of quality metrics from manufacturers and three optional ones. It held a meeting to get industry feedback on the metrics on Monday.
Each metric is intended to evaluate a specific part of how the drugs are made. For instance, one proposed required metric is the number of complaints a company has received about a specific product. Another is the number of batches of product that were rejected due to failing quality tests.
The agency would collect that data each year and give each manufacturer a grade that encompasses how they are on all the metrics. What the company does with that grade is up to them.
There is no plan to release the grades to the public, said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. A big reason is context.
The metrics “certainly could be misinterpreted,” Woodcock said. “Because they can be gamed and are not straightforward to understand it would be a disservice to release them to the public.”
Take biologics, which are drugs made from a living organism. One example of a biologic is a vaccine.
A biologic differs greatly from a traditional drug, which is made up of chemicals rather than living organisms. Therefore a biologic can be harder to produce than a traditional drug since they are more susceptible to heat and contamination.
A biologic drug maker may have a higher score on a certain metric but that may not mean they are a poor-quality manufacturer, Woodcock said.
“If they have a higher [batch] rejection rate does that mean they are a bad production line or a good production line?” Woodcock said. “The public isn’t in a position to interpret all of that.”
Another reason is the agency itself needs to understand what these metrics mean. Woodcock said that a final list of metrics won’t be published this year and even then drug makers will need time to collect and report the data and the agency to analyze it.
“We have to understand them and give companies a chance to work with [the metrics],” she said.
Woodcock downplayed drug quality as a safety issue in the U.S.
“It is not common at all for a drug that somebody takes to have a quality problem,” she said. “Having a safety problem is usually an adverse event that is the inherent property of the drug or maybe it doesn’t work very well.”
Those issues are more of a problem with the design of the drug, and not the manufacturing of it, she said.
Though she said quality problems among regulated drugs are uncommon, there is still a problem with substandard products and counterfeits. There have been highly publicized incidents of counterfeit drugs reaching U.S. patients in the past couple of years, most notably involving fake botox and even some cancer meds.
Woodcock recommended that patients not buy any pharmaceuticals online unless they are from a certified online pharmacy or an insurer’s distribution network.
“We have had consumers given labels in Turkish,” she said. “You know that didn’t go through U.S. distribution channels.”
She added that sometimes a website will say they are peddling drugs from Canada but they may actually be counterfeit.
A 2013 law required the FDA and industry to set up a system to electronically track and trace pharmaceuticals as they go from the manufacturer to the pharmacy. The goal of the system is to ensure there is no chance of counterfeit drugs getting into U.S. markets.
Experts say that the FDA could provide more information on drug quality.
“The FDA is opaque,” said Roger Bate, a scholar with the think tank American Enterprise Institute. “There are numerous data that are important and I accept that much is proprietary to companies, but much is not and is still not disclosed.”
Bate gave an example of data that is supposed to show that a generic drug is equivalent to the brand-name drug it is copying.
“Showing where your product might be slightly different to another generic is important for doctors to know, since it is quite possible that a generic is bioequivalent to the innovator but two generics are not bioequivalent to each other,” he told the Washington Examiner Monday.
Filed under: General Problems
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