Drug Preemption Could Ultimately Harm Big Pharma
A dangerous trend seems to be emerging as legislators and consumer groups pressure the U.S Food and Drug Administration to rethink their decisions on drugs and products. In the case of Wyeth vs. Levine, drug preemption is being considered by the Supreme Court that if found in favor of the drug company, will immunize pharmaceutical companies from lawsuits and give consumers no legal recourse when harmed by an FDA approved drug or product. Most recently a panel of toxicology experts said the FDA did not properly assess the potential health risks posed by the chemical bisphenol A (BPA) found in plastic bottles which some studies have linked to cancer, diabetes, heart disease and developmental delays in children. They further accuse the FDA as relying too heavily on studies funded by the chemical industry in making its decision that BPA posed no health risks. Another example is the detritus left from the Avandia mess. Congress got involved, the press had a heyday and most importantly Glaxo, the manufacturer of Avandia, had not conducted studies that could definitively disprove the allegation that is caused heart attacks. What is the link between these issues? An already overburdened and pressured agency will ultimately have sole responsibility and accountability if a drug or product is found to harm consumers. The immediate threat to the drug industry isn't lawsuits, which big pharma has shown it can beat with their large reserve of funds for such casualties. It's the fact that safety controversies, such as BPA, have demoralized the FDA, made it defensive and made it impossible to get new drugs approved. Bottom line, if preemption increases pressure on the FDA, drug companies would suffer. If drug preemption is approved it could make the FDA more vulnerable to political pressure because the politicians gave the agency the absolute word on drug safety thus the next “miracle” drug may never be approved because of the FDA’s fear. As an afterthought Canada has moved to ban plastic baby bottles containing BPA and several U.S. states are considering restricting its use.
