Dear Chairwoman McMorris Rodgers and Ranking Member Pallone:
On behalf of nearly 40,000 people with cystic fibrosis, the Cystic Fibrosis Foundation urges you to take action to address drug shortages, which force patients to go without critical medication and jeopardize their health.
Cystic fibrosis is a life-threatening genetic disease that causes the body to produce thick, sticky mucus that clogs the lungs and digestive system, which can lead to serious infections. As a complex, multi-system disease, CF requires an intensive treatment regimen including multiple medications. For people with CF, it is not uncommon to take seven therapies every day, and as many as twenty. While advances in CF care are helping people live longer, healthier lives, the inability to access needed medication is a serious threat to our community.
We appreciate efforts to mitigate drug shortages and support passage of H.R. 3008, 3793, and 3810 to ensure patients will have access to all needed medications.
Drug Shortages and CF
Like many patient populations, people with CF have experienced serious shortages of essential medications. Most notably, many antibiotics used by people with CF (including amoxicillin, clindamycin, gentamicin, and rifampin) are currently on the Food and Drug Administration’s (FDA) drug shortage list and others have recently been in shortage (tobramycin, ceftolozane-tazobactam, cefazolin, imipenem-cilastatin, cefoxitin, and ceftazidime-avibactam). People with CF can suffer from frequent, sometimes life-threatening infections and rely on antibiotics to maintain their health. Moreover, people with CF may have limited treatment options due to antibiotic resistance or the type of bacteria they culture, so it is imperative that all approved antibiotics are accessible and available to them. In addition to antibiotics, people with CF have faced shortages of other critical medications, including albuterol and hypertonic saline.
Cystic fibrosis is a serious, chronic disease, capable of causing irreversible damage if left untreated, and people with CF cannot afford to go without these therapies. It is therefore essential that policymakers act to address drug shortages.
H.R. 3008, 3793, 3810
The CF Foundation supports this package of legislation to help mitigate drug shortages. Specifically, these bills would help the FDA better track, anticipate, and understand potential shortages using information about demand for drugs and drug supply chains, allowing the agency to initiate mitigation strategies sooner. It would also improve FDA’s ability to work with drug sponsors to extend shelf-life dates of drugs in shortages to safely increase supply.
Drug shortages are a serious threat to patients and we thank you for your attention to this issue. We look forward to partnering with you to pass this important legislation.