It was in February of 1980 that U.S. President Jimmy Carter signed the first Presidential Proclamation designating the week of March 8, 1980 a special time of the year to highlight and celebrate the contributions of women to events in history.
By 1987, Congress had passed Public Law 100-9, designating March each year as Women's History Month. Since then, every U.S. president has issued an annual proclamation calling attention to this special observance.
Women’s History Month offers an important opportunity for us to shine a light on the extraordinary legacy of trailblazing American women and girls who have built, shaped and improved upon our Nation,President Biden wrote in his proclamation.
We in the generic pharmaceutical and biosimilars sectors have especially benefited from the vision and leadership of women.
Women like the late Dr. Agnes Varis, who was one of the founders of what is now AAM, and who during the 1984 Hatch-Waxman negotiations fiercely defended the generic industry position that prescription drug legislation must assure a fair balance between access and innovation.
Dr. Carole Ben-Maimon, who in 2000 helped shepherd the merger of three generic trade associations into one strong, united advocacy voice and a few years later was one of the first industry leaders to testify before Congress on the needed for a biosimilars approval pathway.
Entrepreneur and visionary Jean Hoffman, who 30 years ago developed a strategy to supply quality APIs for the nascent U.S. generic drug industry.
- Thank you, Agnes Varis | Association for Accessible Medicines (accessiblemeds.org)
- Thank you, Carole Ben-Maimon | Association for Accessible Medicines (accessiblemeds.org)
- Thank you, Jean Hoffman | Association for Accessible Medicines (accessiblemeds.org)
Women also have made profound contributions in the generic and biosimilar regulatory arena. Former FDA Commissioner Dr. Margaret Hamburg was an avid supporter of affordable generic medicine and regularly spoke at our annual conferences. In 2013, Dr. Hamburg praised generic manufacturers for contributing more than $1 trillion in savings to the health care system over the past decade, adding
there are few American households that have not benefited from the success of the generic drug industry.1
Current Acting Commissioner Dr. Janet Woodcock, who for more than a decade has attended our generic and biosimilar events, said in 2019,
As an agency, we have never been more confident in the safety, effectiveness and quality of FDA-approved generic drugs than we are today.She said the generic drug industry,has grown from modest beginnings into a major force in health care.2
In 2016 testimony before the House Energy and Commerce Committee, Dr. Woodcock said of biosimilars,
The development of this new [biosimilar] market segment should expand opportunities for technical innovation, job growth and patient access to treatment.3
I am proud to be AAM’s Executive Sponsor of Women in Health Policy (WiHP), which emerged out of the need for women to amplify their professional advancement and share their cross-sector health care policy experience and expertise. This nonpartisan community prioritizes inclusion and diverse perspectives—and has grown to 670 members since its launch in 2017.
If you are a women working in health policy, considering joining our network via the free WiHP LinkedIn group.
As we observe Women’s History Month, we hope you’ll share your stories and remember to give thanks to the women you know for their contributions to our industry, our nations and our society.
By Christine Simmon, Senior Vice President, Policy & Strategic Alliances; Executive Director, Biosimilars Council
- FDA commissioner praises generic industry's efforts on quality, shortages, follow-on biologics in GPhA speech | Drug Store News
- Safety, Efficacy, and Quality Remain Top Priorities as We Continue Our Work to Expand Access to Cost-Saving Generic Drugs for the American Public | FDA
- Biosimilars Implementation | FDA