Drug Topics - November 12, 2007 - (Page 11)

www.drugtopics.com NOVEMBER 12, 2007 DRUG TOPICS 11 Of Interest to Pharmacists 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 fooddrug 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. DT STRANGE Rx Stories Are you stupid? A new patient came in with a prescription for Allegra (fexofenadine HCl , sanofi-aventis). As I put his insurance and demographic information into the computer, I asked him if he had any allergies. He just looked at me like I was stupid and said, “Yeah, that’s why I need Allegra.” Jason D. North, Pharm.D. Illustration: Lisa Goldrick Prestonsburg, Ky. If you have a “Strange Rx story,” send it to Drug Topics, Strange Rx Stories, 123 Tice Boulevard, Woodcliff Lake, NJ 07677-7664. http://www.drugtopics.com

Table of Contents Feed for the Digital Edition of Drug Topics - November 12, 2007

Drug Topics - November 12, 2007 Contents Drugs Often Associated with Errors Wanted: More Convers to Drug Decision Tools MSRA Takeoff Raising Alarm Bells U.S. Still Volnerable to Drug Counterfeiting Strange Rx Stories: Are You Stupid? Are Students a Squandered Opportunity The Week at a Glance

Drug Topics - November 12, 2007

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.