By Dr. Marietta E. Shapiro, Public Citizen health care fellow
A new survey indicates strong consumer support for a more definitive and direct authority of the federal government over compounding pharmacies.
Commissioned by the Working Group on Pharmaceutical Safety, a national poll of 800 randomly selected registered voters was conducted to help inform policymakers about the opinions and preferences of the public regarding the safety, quality and oversight of drugs. The organization is led by former Secretary of Health and Human Services and Wisconsin Governor Tommy Thompson, along with pharmacoepidemiologist and pharmaceutical safety expert Sarah Sellers.
The most salient findings from the survey include the following:
- 87 percent of those polled said that it is very important for their doctor to notify them if they are prescribed a non-FDA approved medication.
- 83 percent declared that if their doctor were to prescribe a drug that does not have FDA approval, it is very important also to be informed of FDA-approved alternatives, if available.
- 77 percent of respondents expressed concern when they were told that the FDA does not currently verify the safety, effectiveness or manufacturing quality of compounded drugs.
- 86 percent found it disconcerting to learn that not every prescription drug sold to patients in the U.S.A. has been evaluated and approved by the FDA.
- 77 percent of voters back FDA regulation of compounded drugs and compounding pharmacies.
Patients should be able to expect that any and all drugs received in a clinical setting are safe and effective. However, this is not always the case. Last year, thousands who were given epidural steroid injections distributed by the New England Compounding Center were not aware that the contents were tainted and potentially lethal. More than 700 illnesses and 60 deaths nationwide have been linked to the fungal meningitis outbreak caused by exposure to contaminated products from this Massachusetts-based company. This tragic incident highlights the critical need to clarify and strengthen governmental regulation of compounding manufacturers.
Traditionally, compounding pharmacies were intended to prepare individually customized drugs prescribed for patients with unique needs that cannot be met by commercially available, FDA-approved medications. For example, a compounding pharmacist may modify the dose, form and taste of an existing adult-dosage tablet for a child who requires a weight-appropriate dose, liquid solution, and tolerably flavored medication. These small community pharmacies have been suitably monitored by state boards.
Recently, however, the compounding pharmacy industry has expanded, and there has been a rapid growth in the number of companies mass producing standardized drugs and engaging in interstate commerce under the guise of “compound pharmacies.” These larger compounding pharmacies operate like conventional drug manufacturers while evading FDA regulations. Since state legal enforcement may be limited and inconsistent, non-traditional compounding pharmacies may get away with poor practices that enable production of drugs possessing suboptimal potency, purity and sterility. The state legislation detailing the degree of federal accountability, control and scrutiny to which these compounding manufacturers should be subject is often inadequate. If the federal government does not take efficient and swift actions, our citizens may be vulnerable to another major public health crisis.
To ensure a more expedient and favorable resolution to the compounding pharmacies regulation dilemma, legislators from the House and Senate should consider what the public wants. Prompt legislative efforts are imperative to improve the safety and integrity of the nation’s drug supply and to protect the overall health and wellbeing of American citizens.
Dr. Marietta E. Shapiro is a Public Citizen health care fellow