UH Hilo pharmacy faculty member heads FDA advisory team

New technology that has revolutionized pharmaceutical manufacturing should be considered when the U.S. Food & Drug Administration (FDA) issues or changes guidelines in areas such as nanotechnology and testing for lead, said a panel of experts led by a professor from the University of Hawaiʻi at Hilo.

The Advisory Committee for Pharmaceutical Science and Clinical Pharmacology gave its recommendations to the FDA after a recent meeting in Washington, D.C. The chair of the committee is Kenneth R. Morris, professor in UH Hilo’s College of Pharmacy.

The committee examined a broad range of topics related to drug products that are under consideration by the FDA. Topics for the July meeting included:

• testing of lead in pharmaceutical products
• advances in the use of nanotechnology, which uses materials that are smaller than the width of a human hair, in product design
• equivalency testing in brand and generic drugs

“In each of these areas, the science behind the production of pharmaceutics evolves as new technology becomes available,” said Morris, who has been involved in various FDA projects for nearly a decade. “Our committee is charged with examining emerging scientific issues that may affect how the FDA guides the pharmaceutical industry, so we need to look to the future.”

The team, comprised of seven members of the academic and industrial pharmacy community, advises Helen Winkel, FDA’s director of the Office of Pharmaceutical Sciences. Her office focuses mainly on the review of the quality of pharmaceutical products before they are approved for market. This includes prescription drugs, both branded and generic, as well as other products under the regulatory responsibility of the FDA.

During the two-day meeting, the panel listened to testimony from interested citizens and groups, including Darrell Abernathy, chief science officer for the United States Pharmacopeia (USP), which is the official public standards-setting authority for all pharmaceutical products manufactured in the U.S. Abernathy told the panel USP- specified lead tests don’t work as well as more modern methods.

“Lead in pharmaceuticals for the U.S. has been monitored for many years and hasn’t been a problem,” Morris said. “But given the recent findings of lead in toys from China, it’s important to be vigilant and to make sure the public knows what’s being done to protect them.”

There is no safe level for lead, but experts in the field told the panel that the toxicity of lead may change if there are other materials in a product. That means accurate tests are absolutely essential in formulating regulations, Morris said.

“In the past, limits may have been set because a better method of testing didn’t exist, but that’s not the case now,” Morris added. “Given the newest techniques readily available in the industry for testing, setting limits should not be based on how good the test is but on keeping lead below a level that is known to cause health problems.”

In addition, the committee advised the agency to gather more information on safe exposure limits for different populations. For example, a person with kidney disease can stand less exposure than a healthy person of the same age.

The committee also advised the agency to collect more data on nanotechnology because they were split in their opinion about how to identify a product using the relatively new science.

“In order to determine whether a product should be regulated differently than conventional drug products, we needed to have a way to define nanotechnology,” Morris said. “Our advice was to consider new guidelines if the function is dependent on the size of the technology and isn’t sufficiently covered by current guidelines.”

The second day of the meeting was devoted to looking at the efficiency of traditional testing methods for drugs that are absorbed for different reasons. For example, a drug might be taken for conditions such as stomach ulcers but not intended to get into the blood stream. In the past, these tests have been tested on human patients through clinical trials, but new technology may allow all testing to be done in the laboratory that may duplicate some of the same reactions.

“More elaborate clinical tests are very expensive and may needlessly expose patients to drugs they may not need,” Morris said. “Tests in the laboratory without trials in humans need to show that a drug works the way it’s supposed to when it’s released in the bloodstream.”

The committee recommended that, when justified, these laboratory tests be done in the same type of liquid as where the drug is supposed to be delivered. However, if the drug is absorbed in the body, they recommended further tests.

The next advisory committee meeting is being scheduled for early next year.