Here is a copy of a letter that I sent to 9th District Congressman Morgan Griffith about a potentially catastrophic bill that he introduced into the House of Representatives:
I am writing to request that you withdraw the Preserving Patient Access to Compounded Medications Act (PPACMA) that you introduced. This act would create a dangerous loophole in the Drug Quality and Security Act (DQSA) according to Michael Carome, M.D. in the Sept.
2017 issue of Worst Pills, Best Pills News. Apparently, PPACMA would “allow any pharmacy to mass produce compounded sterile drugs for hospitals and doctors’ offices”. But the pharmacies acting under this loophole would not have to “comply with federal quality and safety standards for manufacturing drugs.” Currently, compounding pharmacies that want to mass produce sterile drugs for hospitals and doctors’ offices are required to register with the FDA as “outsourcing facilities” that adhere to FDA safety and quality standards and undergo FDA inspections.
In 2012, the New England Compounding Center (NECC) was responsible for a fungal meningitis outbreak affecting 753 patients and causing 64 deaths. This year in March the company’s head pharmacist was found guilty in federal court on 50 counts of racketeering and mail fraud. His and thirteen other NECC employees’ indictments described “alleged criminal conduct that led to production and widespread distribution of contaminated steroids” labelled as sterile and when tests later showed that the drugs were not sterile. NECC “failed to notify customers, institute a recall or investigate the source of the contamination.”
I know what you said on WDBJ 7 News about limiting the amount of compounded drugs available in doctors’ offices but if the limited amounts are contaminated, what difference do the limits make?
According to Dr. Carome, your bill would “all but guarantee another public health catastrophe like the 2012 NECC fungal meningitis outbreak.”
I know that there is a movement in Washington to massively eliminate regulations that Donald Trump and others believe to be blocking “economic growth”. But aren’t the lives and health of the American people more important than economic growth? What good is a “healthy” economy if it comes at the expense of regulations that keep the American people not only healthy but also safe? PLEASE WITHDRAW THIS BILL!
-Paula Lovern
