Generic Drug Quality in the USA: Get informed

On April 9, 2025, the HCMA was on Capitol Hill. We met with congressional Representatives and Senators to discuss important topics such as safe generic drugs and how dangerous and wasteful step therapy requirements by insurance companies are to patients and families. We represented approximately 5 million patients, their families and healthcare providers as we delivered these messages.


Below we invite you to take action:

It takes just one minute to help us emphasize the importance of these issues that affect the entire Bighearted community. Filling out this form will let your congress members know our concerns about generic drug safety and insurance interference in healthcare and will help us advance legislation that benefits us all!

Click to help the HCMA represent you! 

By following the link letters can be generated automatically and sent to your congressional members, all you need to do is fill out your information, so they know they are hearing from their constituent. Together, we can work toward better transparency, allowing physicians and patients to make educated choices on their medical management.

Click to ACT NOW

Please contact your Members of Congress and encourage them to act on behalf of every American on this critical issue. Generic drugs provide lifesaving, affordable treatment to millions of people each day. Generic drug manufacturing has been steadily moving from advanced economies, such as the U.S., to emerging economies, such as India. Due to the lack of transparency of drug supply chains, the quality risk implications of manufacturing in emerging economies have not been empirically tested. In countless reports, patients have been harmed by poor quality generic drugs for cardiac conditions, seizure disorders, and cancer. Over-the-counter drug Zantac was involved in a $2 billion lawsuit for carcinogens in its product. Americans need to know what they are buying and what they are not.

On June 26, HCMA Founder and CEO, Lisa Salberg, convened a panel of physicians, pharmacists, Department of Defense, and patients for a discussion of concerns around generic drug quality. Hundreds of people have viewed this video, either in person or on YouTube, as the panel discussed the the issues with drugs manufactured outside the United States and what we can do about it. Watch now on Youtube!


Panelists:
Dr. Harry Lever, MD, formerly of Cleveland Clinic
David Light, PharmD and CEO of Valisure
Vic Suarez, Colonel (Ret.), Us Army, MS, PMP, CMRP
Christine Jones, Patient

Other Resources

Take the HCMA's Generic Drug survey

(Only takes 5 minutes to complete)

Take Survey

ProPublica has done a series of articles on generic drugs in the United States.  For more information visit our blog.


MedShadow Foundation Webinars on Generic Drug Quality


MedShadow's mission is to provide independent, evidence-and science-based information. Our service and investigative journalism enables people to make informed decisions and we strive to stimulate public conversation aimed at reforming the drug manufacturing processes to ensure that we are all better protected.


MedShadow is a nonprofit foundation that focuses on the safest ways to take over-the-counter (OTC) and prescription (Rx) medications. Our name derives from the fact that side effects can sometimes be difficult to recognize, which is why we work to illuminate and explain medication reactions that may be minimized or obscured.

The People's Pharmacy empowers you to make wise decisions about your own health, by providing you with essential health information about both medical and alternative treatment options. 


Founded by journalists and scientists, Joe and Terry Graedon, The People's Pharmacy has received recognition  from  the American Medical Writers Association and American Association of Orthopedic Medicine, among others, and are former Federal Trade Commission on Non-Prescription Drug Advertising and Rule Making consultants.

Citations

ProPublica:
We Spent a Year Investigating How the FDA Let Risky Drugs Into the U.S. Market, by Brandon Roberts, Debbie Cenziper, Megan Rose and Irena Hwang

June 17, 2025.

ProPublica Sued the FDA for Withholding Records About Drug Safety, by  Katherine Dailey and Jessie Nguyen, Medill Investigative Lab

June 18, 2025.

Are All Generic Drugs Created Equal? An Empirical Analysis of Generic Drug Manufacturing Location and Serious Drug Adverse Events
In Joon Noh, John Gray, George Ball, Zachary Wright, and Hyunwoo Park, POMS,First published online February 6, 2025.

Hemorrhagic and Thrombotic Events Associated with Generic Substitution of Warfarin in Patients with Atrial Fibrillation: A Retrospective Analysis
Sameer R Ghate, Joseph E Biskupiak, Xiangyang Ye, Michael Hagan, Winghan Jacqueline Kwong, Eben S Fox, and Diana I Brixner
Annals of Pharmacotherapy, Volume 45, Issue 6.