Skip to main content
generic pills hero

Generics Access Project, patient advocacy orgs urge Congressional action to alleviate drug shortage crisis

The organizations sent a letter on May 21 to the Senate HELP and House Energy & Commerce leadership to stress congressional action to alleviate the worsening drug shortage crisis.

The Generics Access Project and 46 patient advocacy organizations sent a letter on May 21 to the Senate HELP and House Energy & Commerce leadership to stress the urgent need for congressional action to alleviate the worsening drug shortage crisis. 

GAP noted that a record high of 323 prescription medicinesthe majority of which are affordable, generic medicinesare currently in shortage. Generics make up 91% of all prescriptions filled in the U.S. and are critical in expanding patient access to affordable, safe, and effective treatment options.

"While Congress, the Administration, and regulatory agencies have held hearings, opened RFIs, and introduced “potential solutions,” there has been little done to move the needle – and patients are growing wary," GAP said. "That’s why GAP and groups across cancer, diabetes, asthma and allergy, arthritis, and more joined forces to call on Congress to mitigate the current and active risks as well as progressive solutions to the ongoing systemic issues behind the shortages."

[Read more: IQVIA report sizes up medicine use, spending, immunization rates, drug shortages]

“While there is no silver bullet to address drug shortages, our letter highlights recommendations that prioritize patient access and protect the viability of the generics market, including recommendations put forth by U.S. Pharmacopeia and the American Cancer Society Cancer Action Network’s drug shortage task force.”

The letter to Chair Sanders, Ranking Member Cassidy, Chair McMorris Rodgers and Ranking Member Pallone reads as follows:

On behalf of the Generics Access Project (GAP) and the undersigned organizations, we are writing to encourage Congress’ focus on mitigating the ongoing drug shortage crisis by addressing the systemic issues that contribute to the continuation of this issue. GAP is a coalition of patient advocacy organizations across disease states who advocate for policies that promote generic competition and efficient approval of generic medicines. Generic medicines are a critical cost-lowering mechanism for patients and the healthcare system. 

[Read more: IQVIA report sizes up trends in new drug launches, clinical trials, R&D funding]

Ensuring that patients have timely access to these affordable medicines is crucial. The ongoing drug shortage crisis continues to inhibit patient access, causing delays in treatment, forcing patients and clinicians to turn to often less effective treatment options, and leading to patients missing or altering doses to make up for the lack of access. A survey from the American Cancer Society Cancer Action Network showed that one-in-ten patients currently receiving cancer treatment have been affected by the recent drug shortages. 1 This is not unique to oncology. A survey conducted by the American Society of Health-System Pharmacists showed that 99.7% of respondents had experienced shortages of intravenous solutions, emergency syringes, as well as other critical drugs and medical supplies. 2 Patients across disease states have been impacted by these shortages, especially those in which generic medicines are used.

Generic medications are an important resource in expanding access, as more affordable, effective treatment options for patients and the providers who treat them. These medicines make up about 91% of all prescriptions but only about 18% of the prescription spending. However, generic drugs are at an increased risk of shortage in large part due to market forces such as low prices and margins, short-term procurement contracts, and the ability of purchasing organizations to change suppliers. Lower priced generics have a higher likelihood of being in shortage. In the FDA’s 2019 report “Drug Shortages: Root Causes and Potential Solutions,” the first of the root causes discussed is the lack of incentives in place for manufacturers to produce less profitable drugs.

As the drug shortage crisis continues, it is clear that Congress needs to take a systemic and multifaceted approach in establishing policy solutions. Solutions should address both short and longterm needs to help mitigate the current and active risks as well as progressive solutions to the ongoing systemic issues. Manufacturing Establishing models that incentivize the quality and resilience of the supply chain can lead to more sustainable practices and potentially prevent drug shortages before they occur. In the shortterm, bolstering manufacturing practices through economic and policy incentives to ensure the increased capacity to meet the necessary demand of these medications can also help to lessen the potential for drug shortages. Market Structure Generic competition for oral generics, combined with the purchasing power of a handful of large generic purchasing organizations, have led to price deflations for certain oral generics. 

Policies should be considered to support stability in the generic marketplace, ensuring manufacturers do not opt out of making certain generics based on a lack of profitability. Supply Chain Increasing transparency within the supply chain can help stakeholders better anticipate and predict the vulnerabilities that could later lead to drug shortages. Shedding more light on these vulnerabilities allows stakeholders to adjust to help mitigate risks and avoid shortages. Strong supply chain tracking and disruption prediction should be enhanced throughout the entire process to allow for adjustments to be made earlier. 

Further, ensuring that the FDA’s reporting requirements for generic manufacturers are useful in identifying and mitigating future shortages is critical; FDA should prioritize having the right information rather than more information. Awareness Addressing the drug shortage crisis begins with continuing to bring awareness to the root causes. The systemic nature of these ongoing shortages means that a solution cannot be found without understanding all the contributing factors and ensuring that there is a multifaceted approach to solving them. 

[Read more: IQVIA reports global market for medicines to rise to $1.9 trillion by 2027]

GAP would also like to make you aware of resources being created by a drug shortages task force convened by U.S. Pharmacopeia (USP) and the American Cancer Society Cancer Action Network (ACS CAN). The task force, consisting of leading patient advocacy and health professional organizations, has created a drug shortages call to action that contains specific recommendations that are aligned with the solutions outlined above. It is imperative that Congress take meaningful action to address the drug shortage crisis. Access to these medications can often mean the difference between life and death, and patients cannot be left to continue waiting for solutions to be implemented.

This ad will auto-close in 10 seconds