Despite our many controls, U.S. still susceptible to counterfeiting, warns expert

To hear Roger Williams, M.D., CEO of the United States Pharmacopeia, tell it, the safety net protecting the quality of our medications and dietary supplements is weak. The United States is equally susceptible to contaminated drug outbreaks, such as the recent diethylene glycol poisoning that struck Haiti, as developing countries are.

Williams should know—USP is the standard-setting organization, responsible for preparing monographs on prescription drugs in this country. Williams said that while the nation's Food & Drug Administration has a staff of 10,000 as compared with only 40 for another major country, counterfeit drugs can still slip through domestically because 80% of our drug substances now come from overseas. Creating a worldwide FDA would help control drug counterfeiting, but it is not likely to happen any time soon. "I'm not holding my breath," he told the audience.

Speaking at the 16th Annual Murray & Bernard Schuss Memorial Pharmacy Lecture at the Arnold & Marie Schwartz College of Pharmacy & Health Sciences in Brooklyn, N.Y., Williams said the state of affairs involving dietary substances is no better. In fact, "it's a mess and getting messier." The reason is that many vitamins are now imported from abroad without undergoing any review or inspection. Furthermore, vitamins are being added to many foods, forming food-drug combos. An example he cited is "friendly" Coke, which incorporates vitamins. This has made the regulatory review of dietary supplements even more complicated. USP launched a supplement verification program a few years ago to ensure product quality, he added, but only few companies have sought the agency's seal of approval. This leaves consumers wondering who makes their dietary supplements and how safe they are, he said.

Moving on to the subject of generics, which Williams knows intimately about since he worked at the FDA for 10 years before joining USP, he said we are now in the midst of a battle royal similar to that waged back in 1984, when brand and generic firms fought over patents and exclusivity. Congress is working on developing a regulatory pathway to allow approval for biogenerics under the Public Health Service Act. Many big Pharma companies are fighting tooth and nail to keep this legislation from being passed.

Williams said Congress can take two approaches—approve biogenerics as interchangeable with their innovator equivalents or as biosimilars, which have to meet a lesser standard of comparability. If a product is passed as a biosimilar, pharmacists won't have the power to make a substitution. Rather, it's up to prescribers to make any product switches. "So you have to watch what Washington is doing," he warned. "I personally think the comparability category is a little goofy," he added. "So I think I'm on your side," he told the pharmacy students present.

So what can be done to ensure product integrity in this country? Increasing the FDA's resources is one way to start, Williams replied. He's a big supporter of this strategy because all the regulatory agencies and drug compendia in the world account for only about $5 billion in costs annually—that comes to a mere half a year's sales of a blockbuster drug, such as Lipitor (atorvastatin, Pfizer), he explained. He believes firmly that the public should support legislation that appropriates more money for the FDA. "It comes out of your taxes, but, believe me, it's money well spent." Then, of course, pharmacists can prevent faux drugs from reaching patients by checking the products to make sure they are not counterfeit, he added.

Drug counterfeiting is an example of when there is a breach in our standards, Williams continued. USP's job is to create, update, and change the standards for us to follow. But all the standards in the world won't do us any good if there is no check to see that they are enforced by the FDA. That's why the FDA is so important to us, Williams concluded.