As previously discussed, the recent flurry of U.S. Food and Drug Administration (FDA) activity following passage of the Drug Quality and Security Act (DQSA) in November 2013, including the issuance of three draft guidance documents and six warning letters in the span of just a few months, has resulted in several important unanswered questions as to how the DQSA will impact various entities within the compounded pharmaceutical industry.
The U.S. Senate also has taken notice of this activity, and on May 23, 2014, Senator Lamar Alexander (R-Tenn.), the senior Republican on the Senate Health Education, Labor and Pensions Committee and a member of the Senate Appropriations Committee, announced that, at his request, the Appropriations Committee had included language in its Report for the FY 2015 Agriculture Appropriations Bill (Report) directing the FDA to meet with stakeholders, such as doctors, patients and pharmacists, to discuss their implementation concerns. According to the Report, the Appropriations Committee "is concerned that the [FDA] is not meeting with any stakeholders before publicly releasing further guidance," and has directed the FDA to meet with stakeholders "to ensure continued access to safe compounded drugs for which there is a clinical need."
The Report noted that the FDA has made some efforts to clarify implementation of the DQSA. For example, on March 20 and 21, 2014, the FDA conducted an "Inter-Governmental Working Meeting on Pharmacy Compounding" with officials from state boards of pharmacy and national trade organizations to discuss implementation of the DQSA. The FDA also has released three guidance documents regarding implementation of the DQSA, the most recent of which allows stakeholder comment until June 2, 2014. But uncertainty persists within the industry as to how the DQSA will be enforced, particularly with respect to the classification of entities as traditional compounding pharmacies or "outsourcing facilities," a type of entity created under the DQSA that voluntarily registers with the FDA in exchange for the opportunity to compound drugs without a prescription for office use and to ship compounded drugs across state lines without restriction.
The Appropriations Committee's Report accompanied the FY 2015 Agriculture Appropriations Bill, which includes almost $4.5 billion in total funding for the FDA—an increase of $98 million over the total FY 2014 enacted level, and an increase of $12 million for drug safety activities specifically. Some of this funding likely will be used for enforcement activities related to the DQSA, which clarified and expanded the FDA's regulatory authority over compounding pharmacies in the wake of a tragic fungal meningitis outbreak linked to contaminated vials produced by New England Compounding Center in 2012.
According to Senator Alexander's statement, the purpose of the DQSA is to "end confusion and improve communication so we can help prevent another tragic meningitis outbreak." "If the FDA isn't sitting down with doctors, patients, and pharmacists and communicating how it is implementing the law," Senator Alexander continued, "then I will stay on FDA until it does."
These developments present an ideal opportunity for pharmacies, physicians, patients and other stakeholders to ensure that their voices are heard with regard to DQSA implementation.
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