Improving the safety of prescription drugs
WASHINGTON – In November, the Senate passed the Drug Quality and Security Act, legislation aimed at strengthening the safety of compounded prescription drugs in Michigan and around the country in the wake of a deadly meningitis outbreak.
It has been more than one year since the public became aware of what quickly became a far-reaching fungal meningitis outbreak affecting citizens in 20 states including Michigan.
Following an investigation by the Centers for Disease Control and Prevention and the Food and Drug Administration along with local health departments, it became clear the outbreak was caused by contaminated steroid injections produced by the now defunct New England Compounding Center, a compounding pharmacy in Massachusetts.
According to the CDC, over 750 people across the United States seeking pain relief were affected by tainted steroid injections produced by NECC. Over 260 of these victims, more than one third of the hundreds made severely ill from contaminated injections, reside in Michigan; 64 of the victims lost their life as a result of illness, including 19 Michiganians. This tragedy brought a spotlight to bear on the opaque regulation of what are known as mass-compounding pharmacies facilities that produce large amounts of custom-formula drugs.
On a bipartisan basis, members of the Senate and House of Representatives worked through this issue to produce legislation that both strengthens federal authority to regulate mass-compounding facilities and will lay the groundwork for a nationwide system to track prescription drugs. While not as far-reaching as some may have initially intended, the bill we passed represents an important and necessary step forward.
It is important to draw a distinction, as this legislation does, between so-called “traditional compounding” where a pharmacist tailors a particular drug to meet the unique needs of a patient, such as removing a certain dye or altering the dosage level of an adult medication to be suitable for a child and the mass compounding of drugs for wholesale distribution.
Compounding pharmacists have long been regulated by state boards of pharmacy. However, as was made clear in the investigation that followed the meningitis outbreak, NECC, a mass compounding pharmacy, was operating in a regulatory gray area where neither the state nor the federal government took full responsibility for ensuring their facility and compounding practices were safe and sterile.
The Drug Quality and Security Act, signed into law by President Obama in late November, aims to address this regulatory gray area by clarifying the responsibilities of the FDA with regard to the oversight of mass compounded pharmaceuticals. Specifically, it further defines the distinction between traditional compounding and compounding manufacturers that make large volumes of drugs without individual prescriptions.
Under this law, mass compounding pharmacies can choose to register as “outsourcing” facilities that would be subject to new FDA regulatory oversight similar to that of other pharmaceutical manufacturers. And in an effort to provide patients with better information about compounded drugs, the law calls for detailed labeling of compounded drugs and directs the FDA to make available on their website a list of FDA-regulated facilities.
Importantly, this law also will implement a new system for tracking drugs from the manufacturer to the pharmacy in an effort to ensure accountability at every step along the way. This new system will replace the current state tracing laws with a uniform standard and also will establish nationwide drug serial numbers to allow for efficient tracing.
While this law will not compensate those who have been harmed or bring back those who we have lost, I am hopeful it will help to ensure Americans are not faced with a similarly tragic, avoidable situation in the future.
– – –
Carl Levin is the senior U.S. senator from Michigan.