It is hard to believe, but it appears Republicans and Democrats on Capitol Hill have found something on which they agree: Americans should not be killed by unregulated drug compounders. This week committees from both the House and the Senate issued a press release announcing bipartisan support for the Drug Quality and Security Act (Act).
Compounding pharmacies historically were local pharmacies that created patient-specific medications. Common examples of the need for such specialized medications are for patients that need: medications created with specific ingredients (allergies); medications at lower or higher dose than that manufactured (i.e. infants); medication in a form not manufactured (i.e. syrup). For various market reasons traditional compounding pharmacies have become less common. The most common medications that are still compounded are intravenous/parenteral medications.
Traditionally compounding pharmacies were regulated by the states. As true compounding pharmacies dwindled, many hospitals and pharmacies outsourced compounding to large bulk “compounders” that more closely resemble manufacturers than traditional compounding pharmacies. The Federal Food, Drug and Cosmetic Act (FD&C Act) gave the U.S. Food and Drug Administration (FDA) the right to regulate the manufacturing of drugs, whether it be by a pharmaceutical company or a compounding pharmacy.
The Food and Drug Administration Modernization Act of 1997, however, contained a provision that largely exempted compounding pharmacies. Because of conflicting decisions by the 5th and 9th Circuits about whether this provision of the FD&C Act is valid, there are now jurisdictions in which the FDA has regulatory authority over compounders and other jurisdictions where it does not. Barring a decision on the issue by the Supreme Court or an act of Congress, there is no way for the FDA to regulate these bulk compounders.
The Act distinguishes traditional compounders from “outsourcing facilities.” Traditional compounders would continue to be regulated by the states. Outsourcing facilities would be required to register with the FDA and would be subject to its oversight and inspection. The Act also provides for “track and trace” of compounded products to address concerns about counterfeit/stolen drugs and to assist in case of recalls. The Professional Compounding Centers of America conducted a poll that suggests the Act could result in a significant decrease in the number of compounding pharmacies.
There have been numerous incidents where compounding “pharmacies” have produced tainted products that have killed or injured dozens of people in many states. The most significant example is that of New England Compounding Center (NECC), which last year shipped epidural steroid injections contaminated with fungal meningitis which killed four dozen and injured hundreds of others in 23 states. This type of operation is a far cry from your local compounding pharmacy. Without FDA oversight, these manufacturers are not required to report adverse events to the FDA. Additionally, while states are charged with oversight of compounding pharmacies, only two states do random testing of compounding pharmacies: Texas and Missouri. Both states have discovered that there are unacceptable variations in the potency of compounded drugs (25 percent too weak or too strong and potency variations of up to 300 percent).
The Act is expected to receive bipartisan support in congress and be enacted quickly. The millions of Americans that rely on compounded medications deserve to know the medications they are sold have been manufactured in sterile environments and contain the proper amount of active ingredients they need. Hopefully, the Act will achieve this goal. If you would like more information on this subject, contact Russ Abney, a lawyer in our firm’s Mass Torts Section, at 800-898-2034 or by email at Russ.Abney@beasleyallen.com.
Sources: Law360.com; ModernMedicine.com; Reuters
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