Summary

<p>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.</p> <p>Please ask your Congresspersons to support amending the NDAA with the bipartisan "Transparency &amp; Quality in Pharmaceutical Act," to implement a "quality-score system" that would help differentiate between the qualities (active ingredients, contaminants, dissolution rates, and country of origin) of generic drugs produced by different manufacturers and report those results to purchasing agents.</p> <p>The&nbsp;"Transparency &amp; Quality in Pharmaceutical Act" suggests a quality-score system as seen below:</p> <p>RED - High risk of containing chemical quality issues<br />YELLOW - Medium risk<br />GREEN - Low Risk</p> <p><br />The simple red, yellow, and green score alerts purchasers of bulk medications to choose the highest quality at the most competitive price and avoid low quality and higher prices.<br />Together, we can work toward better transparency, allowing physicians and patients to make educated choices on their medical management.</p> <p><br />Citations: <br /><strong>We Spent a Year Investigating How the FDA Let Risky Drugs Into the U.S. Market &mdash; ProPublica</strong><br />https://www.propublica.org/article/fda-methodology-american-medicine-research<br /><strong>ProPublica Sued the FDA for Withholding Records About Drug Safety &mdash; ProPublica</strong><br />https://www.propublica.org/article/propublica-fda-lawsuit-drug-safety<br /><strong>Are All Generic Drugs Created Equal? An Empirical Analysis of Generic Drug Manufacturing Location and Serious Drug Adverse Events</strong><br />In Joon Noh, John Gray, George Ball, Zachary Wright, and Hyunwoo Park <br />XView all authors and affiliations<br />https://doi.org/10.1177/10591478251319691<br /><strong>Hemorrhagic and Thrombotic Events Associated with Generic Substitution of Warfarin in Patients with Atrial Fibrillation: A Retrospective Analysis</strong><br />Sameer R Ghate, Joseph E Biskupiak, Xiangyang Ye, Michael Hagan, Winghan Jacqueline Kwong, Eben S Fox, and Diana I Brixner <br />View all authors and affiliations Volume 45, Issue 6<br />https://doi.org/10.1345/aph.1P593<br /><strong>A data-driven quality-score system for rating drug products and its implications for the health care industry</strong><br />Arash Dabestani∙ Sara Grossman ∙ Joseph P. Nathan ∙ Carl W. Bazil ∙ Ryan C. Costantino ∙ Erin R. Fox ∙ Joe Graedon ∙ John V. Gray ∙ Harry M. Lever ∙ David Y. Light ∙ Robert Makuch ∙ Kevin A. Schulman ∙ C. Michael White ∙ Kenny Yu <br />https://www.japha.org/article/S1544-3191(22)00327-2/abstract</p> <p><strong>We Still Don't Know Who Makes This Drug</strong></p> <p>Rena M. Conti, Ernst R. Berndt, Neriman Beste Kaygisiz, Yashna Shivdasani<br />https://www.healthaffairs.org/content/forefront/we-still-don-t-know-makes-drug<br /><strong>F.D.A. Increases Scrutiny of Some Generic Drugs - The New York Times</strong><br />https://www.nytimes.com/2012/11/01/business/fda-increases-scrutiny-of-some-generic-drugs.html</p> <p>&nbsp;</p>

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