The National Consumers League, the nation's oldest consumer organization, today is calling on Congress to pass long overdue legislation to require rigorous regulation and oversight of compounding pharmacies in light of the recent, devastating meningitis outbreak--resulting from contaminated steroid injections--that has killed 24 Americans, sickened 317, and exposed many thousands more to potentially deadly illness.
“Thousands of helpless consumers and their families who entrusted their health to a clearly flawed system are now rightfully in a panic,” said Sally Greenberg, NCL Executive Director.
“An estimated 14,000 people are at risk for developing fungal meningitis and left to wonder if they will be the next to get sick. Unfortunately, the issue of compounding pharmacies and the potential risk they present to consumers is not new. NCL has supported legislation to provide regulation and oversight over the past decade and a half, but those efforts have been stymied by industry opposition. Now we have 14,000 patients who are paying, some with their lives. This situation cries out for legislation to prevent tragic health care outcomes like this one.”
The multi-state fungal meningitis outbreak (fact sheet) occurred among patients who received a contaminated steroid injection, distributed to outpatient facilities across the country by the New England Compounding Center (NECC), and used in spinal epidural injections and to treat joint pain. As of October 25, 317 people have contracted meningitis and 24 have died.
Compounding pharmacies have been under scrutiny in the past. In 2007, the bipartisan Safe Compounding Drug Act was introduced by Senators Kennedy, Roberts, and Burr to close regulatory gaps – and NCL and many other patient and consumer groups supported the bill, which did not pass. The current meningitis tragedy exposes dangerous gaps in regulation of compounding pharmacies. Rep. Ed Markey (D-MA), senior member of the Energy and Commerce Committee, plans to introduce legislation to strengthen the oversight of compounding pharmacies by requiring such pharmacies to be compliant with basic safety standards, report adverse events to the Food and Drug Administration (FDA), use only drugs approved by the FDA in compounded medicines, and label compounded drugs with a warning that it has not been proven safe and effective by the FDA.
Compounding pharmacies provide a unique service to consumers by reformulating medicines for patients with special medical needs that cannot be met by FDA-approved drugs. However, compounding processes can introduce new risk into the health care system, as evidenced by this tragedy.
“In 2012, patients deserve better. If we want to encourage patient involvement in their health and to use and trust the health care delivery system, we must ensure these types of tragedies do not happen by increasing oversight and safeguards,” said NCL Vice President of Health Policy Rebecca Burkholder."
The legislation introduced in 2007 and legislation that Rep. Markey will introduce are critical patient safety measures that will protect patients from the harm arising from unregulated compounded medicines. NCL will continue to advocate for patient and consumer rights and work with other organizations on strengthening the oversight of compounding pharmacies.
Steps consumers can take
1. Find out if you have taken a potentially contaminated medicine by checking the FDA list of NECC customers and contacting your health care provider.
2. If you have received a potentially contaminated injection, monitor yourself for symptoms and contact your health care provider.
3. Check the FDA and CDC websites for latest information on the outbreak.
4. Remember to always contact your health care providerif you have questions or concerns about your health.