Brown Urges Newly Confirmed FDA Commissioner to Make Drug Security a Key Priority

Senator Also Pressing FDA to do More to Address Youth Vaping Crisis and Improve Access to Biosimilar Medications

WASHINGTON, D.C. – U.S. Sen. Sherrod Brown (D-OH) is urging newly confirmed U.S. Food and Drug Administration (FDA) Commissioner, Dr. Stephen M. Hahn, to do more to improve drug security. In a letter sent to Hahn, Brown invited the Commissioner to work with him to prioritize and advance policies that will help reduce U.S. reliance on foreign-made medications. Recent recalls of the drugs Valsartan and Ranitidine have exposed the vulnerability of the U.S. supply chain. Because these medications are manufactured abroad, it can be more difficult to enforce the same U.S. quality standards. Brown’s letter urges Dr. Hahn to take additional action to ensure all prescription medicines available in the U.S. are safe and effective, regardless of where they are manufactured.

“It is time to prioritize and advance policies to protect the U.S. drug supply chain by increasing transparency, establishing safeguards to prevent the importation of subpar and potentially dangerous products, and reducing our reliance on foreign manufacturing and the sourcing of active pharmaceutical ingredients (APIs). I look forward to working with you on ways to reduce our reliance on foreign manufacturers and improve the safety and security of our drug supply chain for all U.S. consumers,” Brown wrote.

According to a 2019 FDA report, in fiscal year 2018, more than 60 percent of drug manufacturing facilities serving the U.S. market were located overseas. In addition to our reliance on foreign manufacturing facilities, approximately 80 percent of Active Pharmaceutical Ingredients (APIs) are produced abroad – the majority from China and India. Advancing and prioritizing policies to protect the U.S. drug supply chain will reduce U.S. reliance on foreign-made medications and improve drug security. 

Brown also urged FDA to do more to address the youth vaping crisis, as recent reports show chemicals found in e-cigarattes, can be poisonous and result in heart and lung disease, and other health consequences. Finalizing a policy to clear the market of flavored tobacco products that have not undergone FDA review and implementing a more robust program to enforce our nation’s new tobacco 21 law, should be the first step toward addressing this crisis.

Additionally, Brown offered to work with the Commissioner to improve access to biosimilar medications, which are lifesaving drugs that are often too costly for consumers.  Biologics – drugs made using living organisms – currently have the longest exclusivity period of any approved pharmaceutical, which has a chilling effect on innovation, limits competition, and prevents the development and marketability of biosimilars. Allowing more biosimilars to enter the market will save patients, taxpayers, and hospitals money.

Brown met with Dr. Hahn ahead of his confirmation to discuss these same priorities in December, and will continue to follow-up.  

A copy of Brown’s letter can be found here and below.

Dear Dr. Hahn:

Congratulations on your confirmation as the 24th Commissioner of The Food and Drug Administration (FDA).  I appreciated the opportunity to meet with you prior to your confirmation, and look forward to working with you on commonsense solutions to advance and protect the public health and ensure consumer protection remains a top priority for the FDA.

Through the regulation of food, drugs, biologics, medical devices, cosmetics, and tobacco products, the FDA plays a critical role in protecting the public health. As we discussed previously, as Commissioner, I urge you to prioritize efforts to address the following threats to the public health: 1) ensuring drug security, 2) curbing youth vaping, and 3) improving access to biosimilars. I stand ready to collaborate with you on each of these important priorities.

Enhancing Drug Security: the security of our nation’s drug supply must be a top priority for the FDA under your leadership. According to a 2019 FDA report, in fiscal year (FY) 2018 more than 60 percent of drug manufacturing facilities serving the U.S. market were located overseas. The 2008 Heparin crisis that led to the deaths of 149 Americans and the more recent recalls of the drugs Valsartan and Ranitidine have exposed the vulnerability of U.S. reliance on foreign-made pharmaceuticals. It is time to prioritize and advance policies to protect the U.S. drug supply chain by increasing transparency, establishing safeguards to prevent the importation of subpar and potentially dangerous products, and reducing our reliance on foreign manufacturing and the sourcing of active pharmaceutical ingredients (APIs). I look forward to working with you on ways to reduce our reliance on foreign manufacturers and improve the safety and security of our drug supply chain for all U.S. consumers.

Youth Vaping: use of e-cigarettes by youth has skyrocketed. Data from the 2018 National Youth Tobacco Survey confirms that the youth use of e-cigarettes has reached crisis levels. From 2017 to 2018, there was a 78 percent increase in e-cigarette use among high school students and a 48 percent increase among middle school students. Recent research also shows that the chemicals found both in e-cigarettes and the flavors used in them can be poisonous and result in heart and lung disease, among other health consequences. As an oncologist, you are acutely of aware of danger that e-cigarettes pose to young people. It is past time for the FDA to implement common sense regulations to protect America’s youth and promote a harm reduction approach to decrease the rates of combustible tobacco use. The FDA must take swift action to do more to address this public health crisis by finalizing a policy to clear the market of flavored tobacco products that have not undergone FDA review and implementing a more robust program to enforce our nation’s new tobacco 21 law.

Access to Biosimilars:  as you know, the U.S. has the world's largest market for prescription drugs, yet our consumers pay the world's highest prices. More recently, the high price tag for biologic medicines has kept these lifesaving drugs out of the financial reach of many patients who could benefit from them to treat the most severe diseases. While past FDA Commissioners have argued that the Agency does not play a role in the pricing of pharmaceutical products, the FDA has the tools to support more robust competition in the prescription drug market and lower prices for consumers.

It is time for the FDA to take its role in addressing the financial barriers to accessing lifesaving prescription drugs seriously. Biosimilars have the potential to increase competition in the pharmaceutical marketplace and reduce costs for patients as well as state and federal governments. I ask that you work with Congress to build upon the FDA’s existing regulatory framework to better promote access to biosimilars as they become available and facilitate competition in the biologics market so that prices decrease, giving consumers more affordable access to these important medicines.

The issues of drug security, youth vaping, and biosimilars are important issues for the country. Over the comings weeks and months, I look forward to continued engagement and to working together on ways to address these important priorities.

Congratulations, again, on your confirmation, and thank you again for your commitment to engaging on these important issues.

Sincerely,

 

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