FDA: Protecting and Promoting Whom?

Peter Olszewski

The advertisements are well-designed. We see healthy-looking people, doing things they love with family and friends, before they pause to look at the camera and explain how their lives weren’t always this wonderful. They were full of pain and misery – until they discovered the wonder drug. A warm-voiced announcer then explains what the wonder drug does before returning us to footage of our rejuvenated patient, living life to the fullest. In the best pharmaceutical ads, we barely notice the fine print wedged into the bottom third of the screen while a second announcer uses a monotone to rattle off the drug’s alarming side effects and other health warnings. Those ads are targeted to an ever-increasing audience. Nearly 7 out of 10 Americans regularly took at least one prescription drug in 2013, compared to about 5 out of 10 people in 2007-2008, according to Mayo Clinic and Olmsted Medical Center researchers. Though prescription drugs improve the health of millions of Americans, medications also can harm people when not properly tested to discover associated risks. Unfortunately, we here at Scartelli Olszewski have seen too often the injuries people suffer due to lax oversight of the drug industry. The U.S. Food and Drug Administration (FDA) approves drugs and medical devices based largely on data and information supplied by the manufacturers of the products. Though the FDA proclaims itself a “consumer watchdog,” it also states clearly on its website that it “doesn’t actually test drugs itself, although it conducts limited research in the areas of drug quality, safety, and effectiveness standards.” The FDA has approved hundreds of drugs that it later had to recall from the market or issue restrictions on usage. One example is Johnson & Johnson’s anti-seizure drug topiramate, brand name Topamax®, which is also used to prevent migraines. It was first approved in the U.S. in 1996; later, data from the North American Anti-Epileptic Drug (AED) Pregnancy Registry showed that babies born to women using Topamax were at higher risk for developing a cleft lip or cleft palate. In March 2011, the FDA warned that “women taking topiramate should be aware that there is an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy.”A South Carolina woman, Haley Powell, took Topamax from 2006 to 2007. In 2008, her son Brayden was born with a cleft palate. She sued Janssen Pharmaceuticals, the division of Johnson & Johnson that makes Topamax, alleging that the company knew about the birth defect risks but failed to warn doctors, and even concealed safety reports in 2003 and 2005. In November 2013, a Philadelphia jury ordered Janssen Pharmaceuticals to pay Powell $11 million.In the wake of Powell’s award and two additional recent judgments totalling $7 million in damages, Janssen Pharmaceuticals appeared to take a more conciliatory stance. The company soon settled an additional 76 cases in which the plaintiffs alleged that Topamax had caused birth defects. Another 59 Topamax-related cases are pending. Efforts to improve the drug approval process were made in 2007 with H.R. 3580, the Food and Drug Administration Amendments Act, which granted the FDA more authority to conduct better research and reviews of new drugs and devices and to continue to study drugs being marketed. Still, the Institute of Medicine (IOM) released a study in 2012 concluding that the FDA’s “current approach to drug oversight in the post market setting is not sufficiently systematic and does not ensure that it assesses these benefits and risks of drugs consistently over the drug’s life cycle.” The Topamax debacle is just one of the latest examples demonstrating the need for consumer vigilance. As patients, we must conduct additional research and weigh our options before deciding to take medications. We cannot simply trust the government to keep ourselves and our families safe when the drug companies themselves are the ones responsible for reporting issues. Scartelli Olszewski represents victims of defective drugs, helping pursue compensation for their hardships. Contact our office if you or someone you love has suffered due to defective medications.