Can Biologic Drugs Be Trusted?

Earning the right for pharmacists to substitute generic drugs in place of a brand name prescription order written by the physician was a major victory for the pharmacist’s scope of practice. Now that practice has become so commonplace that no one thinks of it as an issue anymore. But I do remember the battles well. Generic drugs were often positioned by the opponents of this new role as inferior products whose quality couldn’t be trusted.

A study published in the January 2011 issue of The Annals of Pharmacotherapy showed that physicians aged 55 years old or older were 3.3 times more likely than physicians between the ages of 25 and 34 to have negative perceptions about generic drugs. The study also revealed the fact that more than 23% of surveyed physicians had some negative perceptions about generic drugs’ efficacy. So the concern about quality still lingers.

According to a Wall Street Journal article (January 13, 2011), the concern about the quality of medications is heating up again—but this time around biologic products. The new health care legislation would make it easier for generic manufacturers of biologics to enter the market. Once again, the issue of quality is part of the argument against such movement in the market.

For me, this discussion raises several significant questions. Did we benefit consumers, payers, and the pharmacy profession by allowing the increased substitution of generic drugs for brand name drugs and also making entry of generic drugs to the market easier? Is the furor over biologic drugs more of the same—or is the science of biologic drug production such that the quality of generic products entering the market can’t be trusted? What do you think?