By Ralph Tarantino, PhD

Pharmaceutical Consultant and Principal, SteriTech Solutions, LLC

Middletown, NJ

Let’s not forget the reason for the FDA’s existence. The agency was formed to assure the purity of food and drug products (1906). They went on to regulate drug safety (1937) and then drug efficacy (1962). The efficacy regulations were in response to what was truly a safety issue—the use of thalidomide in pregnant women. The FDA is the institutionalized embodiment of the Hippocratic Oath to “first do no harm.” They are cautious because that is their job. Safety does come first. You can always replace a drug that’s not working, but you cannot replace a patient who has died. Suggesting biosimilars could be approved without clinical data is not a very cautious position to take and leads one to wonder about the possible motivation of the FDA in taking that position.

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By Ralph Tarantino, PhD
Pharmaceutical Consultant and Principal, SteriTech Solutions, LLC

Middletown, NJ

The eagerly awaited draft guidance on biosimilars* was finally issued by the FDA on February 9, 2012. It was drafted in the spirit of enlightened health care reform, with a view towards fiscal responsibility and. . . to annoy the nemesis of all that is good in health care, “Greedy Big Pharma.”

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By Ralph Tarantino, PhD
Pharmaceutical Consultant and Principal, SteriTech Solutions, LLC

Middletown, NJ

It wasn’t all that long ago that generic drugs were the exception rather than the rule. On expiration of the innovator’s patent, there would be a somewhat gradual decline in sales due to generic competition, but a loyal following of prescribers and patients would keep the product afloat for a few years. Their faith in the brand name would be buoyed by the know-how behind the product, the innovator’s history of success, and the knowledge that there was a best-in-the-field staff of scientists and technologists who made the product possible. It was good decision making. Drug product choice is a very important decision. [More]