One of the paramount responsibilities of good government is protecting public
health, including ensuring the safety of prescription
drugs. The meningitis
outbreak caused by contaminated drugs from a compounding facility in
Massachusetts, which has killed 37 individuals and sickened more than 550
others, demonstrates that we need to do more to fulfill this fundamental
obligation to American families.
Under current law, drugs that are compounded traditionally — made at a pharmacy based on a prescription for an individual patient — do not fall under the purview of the Food and Drug Administration. Compounding is instead overseen by a patchwork of state and federal regulations. At an October roundtable in Hamden, state professionals talked about what works and how we can ensure that all compounders meet the safety standards that pharmacists in Connecticut are held to.
But in Massachusetts, we saw the current system break down. There, a large producer of compounded drugs masqueraded as a pharmacy and manufactured significant amounts of tainted and dangerous product that was then distributed to more than 20 states, including Connecticut. This is not the first time the public health was risked because of this inadequate, piecemeal oversight, and it will not be the last if we fail to properly address the current regulatory morass.
In the wake of the outbreak, public health officials found multiple health and safety violations at the manufacturer in question. But these violations are not the company's first offense — it has a long record of incidents ranging from inappropriate marketing to sale of another potentially contaminated product. It was even banned from distributing drugs to Colorado unless they were based on a patient-specific prescription. Yet, it was still licensed in many states, and its products were used on thousands of patients. Largely because it was not clear who had oversight and what type of facility this was, it operated in a regulatory limbo for years — until hundreds of Americans became ill and some died from its contaminated products.
We must do more to prevent these outbreaks. These tragedies should have been preventable, if basic regulations had been enforced and it was clear who had oversight of the facility. This outbreak and the corresponding recall make clear that more must be done to ensure that patients have access to safe compounded drugs.
That is why I introduced the S.A.F.E. Compounded Drugs Act, which would clarify the FDA's authority to regulate compounded drugs and improve communication between federal and state regulators to facilitate more comprehensive inspections. It asks the FDA to set minimum production standards — such as compliance with existing recommendations. And, based on advice from experts in Connecticut, it directs the FDA to offer regional training opportunities for state regulators.
The bill encourages federal and state regulators to share data so we do not see an outbreak like this again. If a company is flagged as troublesome in one state, appropriate action should be taken to ensure unsafe products are not in the marketplace. And each state it is licensed in should be made aware of the trouble. The bill would also make sure that intentionally distributing drugs compounded in violation of the law is a criminal offense.
Compounding takes place in more than 650 pharmacies and 36 hospitals here in Connecticut, but we do not have figures for each state or the nation. So my bill requires compounding pharmacies to register with the FDA, so we can at least know how many of these facilities there are nationally. The bill includes a common-sense exemption for small businesses.
As of late November, the median age of affected patients in this outbreak was 64 — so we need to make sure our seniors on Medicare are protected, which this legislation takes steps to do. The bill would also help all patients by requiring compounded drugs to be appropriately labeled.
It is unacceptable for the status quo to continue and for there to be a regulatory limbo that risks patient health. This bill provides a way forward that ensures the protection of families' health, while allowing our pharmacies to do the critical work they do to make sure patients get the products they need.
Rosa DeLauro represents Connecticut's 3rd Congressional District.
Source found here
Under current law, drugs that are compounded traditionally — made at a pharmacy based on a prescription for an individual patient — do not fall under the purview of the Food and Drug Administration. Compounding is instead overseen by a patchwork of state and federal regulations. At an October roundtable in Hamden, state professionals talked about what works and how we can ensure that all compounders meet the safety standards that pharmacists in Connecticut are held to.
But in Massachusetts, we saw the current system break down. There, a large producer of compounded drugs masqueraded as a pharmacy and manufactured significant amounts of tainted and dangerous product that was then distributed to more than 20 states, including Connecticut. This is not the first time the public health was risked because of this inadequate, piecemeal oversight, and it will not be the last if we fail to properly address the current regulatory morass.
In the wake of the outbreak, public health officials found multiple health and safety violations at the manufacturer in question. But these violations are not the company's first offense — it has a long record of incidents ranging from inappropriate marketing to sale of another potentially contaminated product. It was even banned from distributing drugs to Colorado unless they were based on a patient-specific prescription. Yet, it was still licensed in many states, and its products were used on thousands of patients. Largely because it was not clear who had oversight and what type of facility this was, it operated in a regulatory limbo for years — until hundreds of Americans became ill and some died from its contaminated products.
We must do more to prevent these outbreaks. These tragedies should have been preventable, if basic regulations had been enforced and it was clear who had oversight of the facility. This outbreak and the corresponding recall make clear that more must be done to ensure that patients have access to safe compounded drugs.
That is why I introduced the S.A.F.E. Compounded Drugs Act, which would clarify the FDA's authority to regulate compounded drugs and improve communication between federal and state regulators to facilitate more comprehensive inspections. It asks the FDA to set minimum production standards — such as compliance with existing recommendations. And, based on advice from experts in Connecticut, it directs the FDA to offer regional training opportunities for state regulators.
The bill encourages federal and state regulators to share data so we do not see an outbreak like this again. If a company is flagged as troublesome in one state, appropriate action should be taken to ensure unsafe products are not in the marketplace. And each state it is licensed in should be made aware of the trouble. The bill would also make sure that intentionally distributing drugs compounded in violation of the law is a criminal offense.
Compounding takes place in more than 650 pharmacies and 36 hospitals here in Connecticut, but we do not have figures for each state or the nation. So my bill requires compounding pharmacies to register with the FDA, so we can at least know how many of these facilities there are nationally. The bill includes a common-sense exemption for small businesses.
As of late November, the median age of affected patients in this outbreak was 64 — so we need to make sure our seniors on Medicare are protected, which this legislation takes steps to do. The bill would also help all patients by requiring compounded drugs to be appropriately labeled.
It is unacceptable for the status quo to continue and for there to be a regulatory limbo that risks patient health. This bill provides a way forward that ensures the protection of families' health, while allowing our pharmacies to do the critical work they do to make sure patients get the products they need.
Rosa DeLauro represents Connecticut's 3rd Congressional District.
Source found here
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