Many of you may have seen recent stories in the media questioning the accessibility and safety of generic drugs, including those manufactured overseas. These stories, and others like them, could lead to fear and confusion among patients, potentially leading to adherence issues and poor health outcomes. As the medication safety experts on the front lines with patients, it is critical that our members know that ASHP is committed to working with you, our partners in government, and other key stakeholders to help ensure that medications are accessible, safe, and effective, regardless of origin.
We have been in recent contact with FDA leaders to ensure that they fully appreciate the concerns that ASHP and our 50,000 members have regarding the absolute need for quality generic medications, and the need for the entire pharmaceutical industry to adhere to standards of quality. ASHP will continue to meet with FDA, Congress, industry leaders, and other stakeholders to help assure the public that the medications they take are safe and effective, and will strongly advocate for any changes that may need to be made to law or regulation to support that goal.
On Friday, the FDA’s Office of Regulatory Affairs issued a statement that reaffirms their commitment to safety and quality and outlines their risk-based approach to global inspections.
The safety and efficacy of medications is central to ASHP’s patient care and public health mission and we have championed these issues in our ongoing work in a number of areas, including sterile compounding and drug shortages. We enjoy a close partnership with officials at the Food and Drug Administration (FDA) and, as a longtime leader and Board member in the Alliance for a Stronger FDA, have been a vocal advocate for sufficient federal appropriations to the agency so that it has the resources necessary to ensure the safety and effectiveness of medical and other FDA-regulated products.
We will continue to be in close contact with the FDA and will keep you informed on steps they are taking to ensure the quality and safety of generic medications in light of recent stories in the media.
ASHP has also long been at the forefront of efforts to address escalating drug prices, including generic medications, and their impact on pharmacy practice and patient outcomes.
ASHP is a lead member of the Steering Committee for the Campaign for Sustainable Drug Pricing (CSRxP) and is actively involved in other collaborative efforts to identify bipartisan solutions to address skyrocketing drug prices and provide more affordable choices for patients. ASHP strongly supports the need for reforms to address the underlying causes of high drug prices, including increased transparency, competition, and value.
In addition to our work with CSRxP, ASHP is actively engaging Congress on critical issues related to access and affordability of medications. ASHP has submitted 11 statements related to drug pricing to congressional Committees over the past year, and in just this month alone, ASHP representatives have met with two dozen congressional offices, representing the voices of our members on the tremendous impact of escalating drug prices.
Late last week the House of Representatives passed legislation to reduce the cost of generic drugs, by prohibiting brand manufacturers from taking steps to keep generic products from the marketplace, including barring pay for delay tactics, allowing generic manufacturers access to samples of branded products, and removing regulatory barriers to the launch of multiple versions of a generic product.
ASHP is supportive of the drug pricing provisions included in H.R. 987 as they represent important steps to promote competition and ensure that generic drugs reach patients sooner. In the weeks and months ahead, we will take this message to the U.S. Senate and advocate for drug pricing legislation.
We will continue to advocate for policies and regulatory solutions that support safe, effective, and accessible medications for our patients, and will provide updates on new activities, initiatives, and outcomes from our efforts as available. If you have any questions, please feel free to contact ASHP’s Government Relations team. Further, we will plan to keep you updated on this issue and others as new developments arise. Thank you for being a member of ASHP, and for everything you do for your patients.