NEW ORLEANS (AP) -- In an unusual move, the Food and Drug Administration is partnering with the drug industry to research ways to speed up and streamline how the government regulates the quality of medications.
The FDA "tends to be conservative and maybe to ask for more (testing) than it needs" to ensure drug quality, said Dr. Roger Williams, FDA's deputy director for pharmaceutical science.The new Product Quality Research Institute may "give us the information we need so we can lighten up," he said.
The PQRI is a nonprofit research collaboration between scientists from the FDA, the drug industry and the American Association of Pharmaceutical Scientists, which announced Tuesday it will run the new institute.
The institute won't test specific drugs -- or replace the clinical studies that drugmakers must do to prove a medication is safe and effective before the FDA lets it sell.
But beyond those clinical trials are hundreds of chemical and manufacturing steps invisible to patients and doctors that companies must take to prove each tablet or injection or inhaled puff of a drug is high quality, with the proper purity, potency and stability.
Those FDA-required steps can delay a new drug's sales, or cost companies millions to make a manufacturing change to an existing drug -- even something as simple as switching from one factory to another.
Recent University of Maryland research concluded FDA could safely cut certain requirements when drug manufacturers make simple factory changes, such as FDA's demand for multiple test-run batches when a new factory opens. The FDA thought the research was good enough that it made the cuts and says the changes didn't hurt drug quality but may have saved industry $70 million.
That sparked development of the new institute to research other ways FDA can ensure quality without unnecessary testing.
For example, say the maker of a new inhaled asthma medicine wants to change the design of the inhaler itself -- not the drug inside it. Final studies of the drug are almost finished. But inhaler devices can affect the particle size of the drug they emit, or how much drug reaches the lungs.
Currently, there are no ways to prove changing the inhaler didn't hurt the medication's effectiveness without retesting patients, explained toxicologist Tobias Massa of Eli Lilly & Co. The institute could research alternatives that FDA might one day accept in place of that long, expensive retesting.
The FDA does some of its own research in studying what safety rules make the most scientific sense for drugs, foods and other consumer products. But Congress has slashed FDA's research budget in recent years, forcing it to turn more to industry groups and scientific societies like the AAPS for the latest studies on safety processes.