B. Douglas Hoey, R.Ph, MBA
Congress recently reauthorized the Prescription Drug User Fees Act (PDUFA) with overwhelming bipartisan support. This legislation, first enacted in 1992, allows the FDA to collect fees from drug manufacturers to fund the new drug approval process and requires Congressional reauthorization every five years. It was considered “must pass” legislation for this Congress. The National Community Pharmacists Association (NCPA) was pleased to support this legislation on behalf of the more than 23,000 independent community pharmacies nationwide and the patients they serve.
The current reauthorization establishes critical generic drug user fees which will expedite FDA approvals of generic drugs over the coming years. When used appropriately, generics are cost-effective and offer savings for plan sponsors and patients. As these drugs come to market, it is important that patients have access to these savings. It is also worth noting that community pharmacies dispense generic alternatives 20% more often when compared to mail order pharmacies owned by pharmacy benefit managers (PBMs) – part of what makes local pharmacies a critical component to reducing health costs.
While the primary purpose of the legislation was to reauthorize existing user fees while creating new user fees for generic drugs, Congress also included several provisions to increase safe access to prescription drugs. These provisions are strongly supported by the independent pharmacy community. For example, the legislation takes a step forward in addressing the issue of drug shortages by directing the Drug Enforcement Administration (DEA) to provide timely approval or denials for requests to increase production of Schedule II medications when these decisions could alleviate shortages. Congress further directed the Government Accountability Office (GAO) to conduct a study to investigate the causes of shortages and to offer recommendations to further address this issue. Drug shortages increase acquisition costs to pharmacies, and often require the pharmacy to dispense the medication at a loss due to reimbursement rates that are too low or belatedly increased to reflect market costs. Drug shortages also create access issues for patients who have a difficult time obtaining their medication. Independent community pharmacies have experienced shortages with medications to treat ADD and ADHD, among other conditions.
Congress also provided for the interoperability of prescription drug monitoring programs. The new law allows the Secretary of Health and Human Services (HHS) to facilitate the exchange of prescription drug monitoring program information across state lines to prevent abuse and requires a report on such facilitation. This could allow pharmacy to be a larger part of the solution to prescription drug abuse by making it easier for pharmacists to identify patients who may be “doctor shopping.” It also requires HHS to prepare a report on current federal initiatives to ensure safe use of prescription drugs and to identify both gaps and opportunities for further advancement of this issue. In addition, the legislation calls for a thorough study of the problem of rogue, online pharmacy websites, helping to ensure that patients are receiving their medications from a reputable source.
Finally, the law offers assistance to visually impaired and blind consumers by requiring the development of best practices on the issue of accessibility of information in prescription drug labelling for these patients. It also requires the GAO to study the utilization of such best practices. Ensuring visually impaired consumers understand the labels and safely take their medication will help avert dangerous and costly implications of prescription misuse.
While the legislation takes great strides to increase patient safety and access, it is worth mentioning two unresolved issues (1) a proposal to enhance pharmaceutical supply chain security (sometimes referred to as “track-and-trace”) and (2) greater efforts to reduce the abuse of prescription drugs, such as hydrocodone products. We look forward to working with Congress in a bipartisan fashion to address these issues in the near future, without placing costly burdens on small business community pharmacies or undermining health outcomes for patients with legitimate medication needs.
NCPA commends Congress for this bipartisan legislation, which demonstrates that Americans stand united in ensuring patient safety in taking their prescription medication while also taking strides to provide cost effective alternatives.