WASHINGTON DC (October 16, 2019) – The Food and Drug Administration (FDA) has made tremendous strides in recent years towards streamlining the approval process for high-quality and more-affordable generic drugs, and the Association for Accessible Medicines (AAM) and its members applaud the FDA’s staff and leadership for their work. That said, despite the FDA’s efforts, too few patients – seniors in particular – are seeing the savings that should be generated by these record numbers of approval.
On September 24, President Ronald Reagan signed the Drug Price Competition and Patent Term Restoration Act. Better known by the name of its two sponsors, Senator Orrin Hatch (R-UT) and Representative Henry Waxman (D-CA), the Hatch-Waxman Amendments gave rise to the modern generic pharmaceutical industry as we know it.
September 24 marked the 35th anniversary of President Reagan signing into law the Hatch-Waxman Amendments, which provided the framework for the modern generic drug industry and created the proper balance between innovation and access in the pharmaceutical ecosystem.
To celebrate this important day, AAM handed out over 1,500 custom-made Georgetown Cupcakes on Capitol Hill. AAM members and key stakeholders also received a box of cupcakes at their offices. AAM encouraged everyone to take a celebratory photo with a cupcake and post in social media using the hashtag #hb2generics.
Since 2006, the Medicare Part D program has successfully provided seniors access to lifesaving medicines while stewarding taxpayer resources. Today, the program serves more than 45 million seniors. The average basic Part D premium for 2020 is expected to decrease for the third consecutive year, resulting in $1.9 billion lower premium costs for beneficiaries during that time period.
It was September 24, 1984. Amadeus, Places in the Heart and Irreconcilable Differences were playing in theaters, and the number one song in America was John Waite’s “Missing You.” The New York Mets’ Dwight Gooden had just broken the rookie strikeout record, though the rival Chicago Cubs ended up taking the National League East that season — only to be defeated by the San Diego Padres in the playoffs, who were in turn defeated by the Detroit Tigers in the World Series.
The unabated high cost of prescription medicines in America has prompted a public outcry for solutions from state and federal policymakers as well as health care leaders. Meanwhile, FDA-approved generic medicines continue to generate competition for more expensive brand drugs and reduce costs for America’s patients for 35 years running. Generic drugs are a core component to lowering drug spending, and the use of generic medicines saved $293 billion in 2018 alone.
AAM Analysis Shows Patients Wait Up to Three Years for First Generic Competitors to Costly Brands
WASHINGTON, DC (September 19, 2019) – The Association for Accessible Medicines (AAM) today released a white paper, “Access Denied: Why New Generics Are Not Reaching America’s Seniors.” It highlights striking new data on the treatment of generic medicines in Medicare Part D, resulting in beneficiaries paying more for their medicines even when lower
The American public is clamoring for systemic changes to address skyrocketing drug prices. Specialty drugs — a fast-growing category that includes biologics and other complex medicines — are of particular concern. These medicines account for only 2% of prescriptions but already represent almost half of all drug spending.
America’s health care system is eager for biosimilars, especially in light of mounting evidence that they deliver increased patient access and savings by providing competition for costly brand-name biologics.
Karin Hessler, Assistant General Counsel at the Association for Accessible Medicines, urges attendees to add their voice to the discussion at the one essential generic and biosimilar conference of the year: GRx+Biosims 2019, November 4—6 in Bethesda, MD.
The conference legal track: