ASHP InterSections ASHP InterSections

May 20, 2019

ASHP is Committed to Ensuring that all Medications are Accessible, Safe, and Effective

Dear Colleagues,

Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP

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.

Sincerely,

Paul

 

February 27, 2017

ASHP Continues Working on Solutions to Rising Drug Prices

Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP

RISING DRUG PRICES have affected virtually every segment of healthcare. From consumers to hospitals to third-party payers, all have been forced to make difficult decisions regarding healthcare choices. Patients and ASHP members’ organizations are feeling the impact of escalating drug prices, as is the entire healthcare system. ASHP is well aware of this alarming trend and is diligently working with a wide array of stakeholders and bipartisan policymakers to explore practical and sustainable solutions.

This problem is about public health and the downstream effects that high drug costs have on the health of patients and the ability of our healthcare institutions to care for them. For example, we know that when patients face higher costs they are more likely to not fill their prescriptions and may even ration their medications. Nonadherence often leads to more expensive therapies or hospital stays due to complications resulting from untreated or undertreated conditions. Payers have also had to make difficult choices in the face of spiraling drug costs, including challenging formulary decisions. Hospitals and health systems may be forced to make difficult decisions to offset rapidly rising drug costs.

Even generic drugs widely used to manage the cost burden on individual patients and our hospitals and clinics are now experiencing dramatic price increases. Instead of a robust marketplace flush with competition that drives prices lower, sometimes there appears to be little or no competition, resulting in a single company producing a generic product. Without competition, manufacturers can raise their prices as high as the market will bear. In 2016, a study commissioned by the American Hospital Association and the Federation of American Hospitals noted that drug spending increased 8.5% in 2015, while inflation increased only 0.7%. This trend cannot be sustained. The study provided an example of one hospital where “the price increases for just four common drugs, which ranged between 479 and 1,261 percent, cost the same amount as the salaries of 55 full-time nurses.” Unfortunately, while this may be an extreme example, the typical drug price increases in a hospital or health system place a heavy burden on the healthcare team and its organization to ensure their patients have access to medication therapies.

In 2016, ASHP joined the Steering Committee of the Campaign for Sustainable Rx Pricing (CSRxP), a coalition consisting of physicians, consumers, payers, hospitals, health systems, and patient advocacy groups. We believe that CSRxP, as a coalition of nationally prominent organizations, has the best chance of effecting change at the national level regarding drug price increases. With ASHP’s input, CSRxP developed a policy platform that seeks to address this problem through market-based solutions, focusing particularly on competition, value, and transparency. ASHP and other members of the Steering Committee have begun conducting joint meetings with congressional staff to discuss bipartisan policy solutions. CSRxP has also been implementing an ongoing media strategy to call attention to drug pricing and place this issue on the national agenda.

Efforts to address the problem through legislation are already underway. For example, S. 297 and H.R. 749 would require the Food and Drug Administration (FDA) to expedite approval of an Abbreviated New Drug Application (ANDA) when a drug is in short supply or little or no competition exists. Another bill, S. 124, would prohibit brand companies from paying generic manufacturers to delay introduction of a generic version, otherwise known as “pay for delay.” ASHP believes these are steps in the right direction, but more can and should be done to promote competition and limit marketplace manipulation through pay-for-delay or restricted distribution.

Also under consideration in Congress is legislation (S. 92, S. 183) that would allow drugs to be imported from other countries, such as Canada, where prices are significantly lower. This approach, however, is not one that ASHP supports, due to safety concerns over the origin of the drug and the disconnect of the pharmacist-patient relationship. Another policy option would be to allow the government to negotiate drug prices directly with manufacturers for drugs covered by Medicare Part D. However, this legislation (S. 348, H.R. 242, S. 41) does not have bipartisan support.

Finally, the Prescription Drug User Fee Act (PDUFA) is up for reauthorization this year and may serve as a legislative vehicle to address this problem. This reauthorization is considered must-pass legislation, and we have already begun discussions with key congressional staff about the policy goals of CSRxP and their potential fit within PDUFA.

ASHP remains an active leader in CSRxP and will continue pushing for solutions to the problem of rising prescription drug prices. As the only national pharmacy organization on the Steering Committee, we will continue to work collaboratively with our partners to provide the perspective of our members and to help ensure that affordable medications are accessible to those who need them.

Thank you for all that you do on behalf of your patients and for being members of ASHP.

Paul

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