FDA Expert: Generics Safe, Effective

A pharmaceutical scientist who spent 30 years with the FDA affirmed the safety and efficacy of generic medications in a report appearing online on October 8, 2012, in the Washington Post.

According to the report, which cited an interview conducted by Consumer Reports, pharmaceutical scientist and consultant for the US Pharmacopeia Vinod P. Shah, PhD, helped develop the guidelines for approving generic drugs during a 30-year tenure at the FDA.

Dr. Shah explained portions of the approval process, including strength, dosing, and administration requirements, while also clarifying the tests used to determine bioequivalence. He also explained the standards for purity and manufacturing quality expected of generic drug manufacturers.

“For all these reasons, I feel very confident that the generic products approved in this country are safe and effective,” Dr. Shah said in the interview. “My gut feeling is that people think brand-name products must be better because they’re more expensive, but that’s a psychological effect, not a real effect. The body does not know whether the drug came from a brand name or a generic company.”

Although the active ingredients must be identical, consumers should be aware that inactive ingredients in oral capsules and tablets do not have the same requirement, Dr. Shah added. Many manufacturers may not know the inactive ingredients in a brand-name medication, he said.

The interview clarifies why certain medications, typically narrow therapeutic index (NTI) drugs, such as antiseizure medicines, blood thinners, and thyroid replacements, cause trouble for patients who switch between brand name and generic drugs, or even between different generic manufacturers.

“For them to work properly, you have to maintain a specific concentration in the blood,” Dr. Shah noted. “You have to regularly check blood levels to make sure the concentration is right. Either a brand name or generic NTI drug can work, but once you have identified a suitable version, it may not be advisable to switch back and forth, even between 2 generics, because the formulation characteristics might be different and affect the blood concentration.”

Dr. Shah also addressed draft guidelines for bioengineered treatments used to treat rheumatoid arthritis and multiple sclerosis, which rely on living organisms to work. “The generics that we’re accustomed to seeing are small molecules that can be easily synthesized without living organisms,” he said. “But these biotech drugs are large molecules that have to be prepared with living organisms in a very complex manufacturing process. The generic manufacturers don’t know how the original manufacturer does it, so they will have to figure it out on their own. It remains to be seen how much cheaper these biosimilars will be than the brand name originals.”