Drug Shortages

AAM Submits Comments to HHS and FTC on the Impact of GPOs and Wholesalers on Access to Generic Medicines

bhart — Thu, 30 May 2024 16:29:03 +0000

AAM Submits Comments to HHS and FTC on the Impact of GPOs and Wholesalers on Access to Generic Medicines

WASHINGTON (May 30, 2024) — The Association for Accessible Medicines, the leading trade association for generic and biosimilar manufacturers, today submitted comments to the U.S. Department of Health and Human Services and the Federal Trade Commission in response to a request for Information to better understand how the practices of pharmaceutical middlemen—group purchasing organizations and drug wholesalers—may be contributing to generic drug shortages.

“The sustainability of competitive generic and biosimilar markets and the continuing supply of Food and Drug Administration approved/licensed generic and biosimilar medicines for patients, uninterrupted by shortages, is in jeopardy,” said David Gaugh, Interim President and CEO of AAM. “Although generic and biosimilar manufacturers have contributed to dramatically lower rates of health care spending, their ability to continue to provide affordable medicines is threatened by excessive consolidation of intermediary participants – group purchasing organizations (at both the retail and hospital levels), wholesalers, and pharmacy benefit managers.

The letter requests that the FTC issue a section 6(b) Order to investigate the contracting practices of buying groups that contribute to the root causes of drug shortages. AAM also suggests that the agencies issue new Statements of Antitrust Enforcement Policy in Healthcare that lower the (now withdrawn) “market power” safe harbors for buying groups; and revise and/or clarify the Anti-Kickback Statute safe harbor provisions to exclude anticompetitive fees and charges imposed by Buying Groups.

Gaugh continued, “As AAM notes in its full written statement, without remedial action, the high concentration of buying power in the generic and biosimilar markets – combined with anti-competitive contract terms – will continue to cause harm to patients and consumers in the form of terminated or abandoned products and drug shortages. This, combined with poorly designed federal and state policies, has driven generics and biosimilars to unsustainably low prices. The agencies should act to reverse this trend by striking the right balance between affordability to the health care system and incentives to reinvigorate robust generic and biosimilar markets.”

View Full Letter

For media inquiries, contact the Communications department at media@accessiblemeds.org.

About AAM

The Association for Accessible Medicines, your generics and biosimilars industry, is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers of finished generic pharmaceuticals and biosimilars, manufacturers of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 17.5 percent of total drug spending.

About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

bhart Thu, 05/30/2024 - 12:29

Issues

Drug Shortages

Generic Supply Chain

Drug Prices

AAM White Paper on Shortages

eklinger — Thu, 22 Jun 2023 16:05:01 +0000

AAM White Paper on Shortageseklinger Thu, 06/22/2023 - 12:05

Generic medicines are the backbone of the U.S. prescription drug market, supplying more than 9 out of every 10 prescriptions. And the availability of generic medicines overall is remarkably stable – even during challenges such as the COVID-19 pandemic.

Nonetheless, drug shortages, which hit crisis proportions between 2010 and 2011, can be a challenge for manufacturers, providers, and patients. Due to aggressive efforts by industry and the Food and Drug Administration (FDA), the incidence of shortages has declined, but recent reports suggest a rise in shortages in 2023.

Read Report

Share Your Voice

To help raise awareness of the essentialness of generic medicines to patients and our healthcare system, join our industry's 4GRxANTED campaign. The #4GRxANTED campaign asks people to  record a video or share a story explaining who or what in their lives they take for granted but shouldn’t and post it on social media. For every video created, liked or shared with the hashtag #4GRxANTED, the generics industry will donate medicines to Direct Relief, a humanitarian aid organization that provides medical assistance to people affected by poverty or emergencies.

Issues

Drug Shortages

How Inflation Penalties for Generic Medicines Could Worsen Drug Shortages

mstanford — Thu, 02 Dec 2021 16:00:58 +0000

How Inflation Penalties for Generic Medicines Could Worsen Drug Shortagesmstanford Thu, 12/02/2021 - 11:00

AAM Buy American Fact Sheet

eklinger — Fri, 20 Mar 2020 16:08:27 +0000

AAM Buy American Fact Sheeteklinger Fri, 03/20/2020 - 12:08

A diverse, resilient supply chain for prescription medicine will moderate the risk of drug shortages and ensure patient access during the COVID-19 pandemic and beyond.

Developers of generic and biosimilar medicines support diversification of the pharmaceutical supply chain — and incentives to increase manufacturing in the United States — but we must not hinder our response to the COVID-19 emergency.
Any draconian restrictions on sourcing of ingredients or finished products could limit the ability of the U.S. government to provide medicines to veterans, soldiers and other patients during or after this time of national emergency.

Download Fact Sheet

View Letter to the President

Issues

Drug Shortages

AAM Interim CEO Jeff Francer on COVID-19

jfrancer — Fri, 28 Feb 2020 19:20:50 +0000

AAM Interim CEO Jeff Francer on COVID-19 jfrancer Fri, 02/28/2020 - 14:20

AAM Statement on 2019 FDA Drug Shortages Task Force Report

rschwartz — Tue, 29 Oct 2019 14:44:43 +0000

AAM Statement on 2019 FDA Drug Shortages Task Force Report

WASHINGTON DC (October 29, 2019) – AAM applauds FDA for recognizing the multi-faceted challenges that can lead to drug shortages. In particular, deteriorating market conditions have led to sustainability issues in the manufacture of certain medicines. AAM and its members commit to working with FDA and policymakers to advocate for policies to ensure a healthy, sustainable market for safe, effective and affordable medicines for patients.

View task force report: Drug Shortages: Root Causes and Potential Solutions

MEDIA CONTACT:
Rachel Schwartz
202.249.7147

About AAM

AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 22 percent of total drug spending.

About the Biosimilars Council

rschwartz Tue, 10/29/2019 - 10:44

Issues

Drug Shortages

Generic Prescription Drug Shortage Bills

eklinger — Fri, 01 Feb 2019 21:07:34 +0000

Generic Prescription Drug Shortage Billseklinger Fri, 02/01/2019 - 16:07

AAM’s core mission is to improve patients’ lives by advancing timely access to affordable, FDA-approved generic and biosimilar medicines. AAM is the nation’s leading trade association for manufacturers and distributors of generic and biosimilar prescription medicines. Our members provide more than 36,000 jobs at nearly 150 facilities, and manufacture more than 61 billion doses of prescription medicine in the US annually.

Key Points:

From 2010 to 2016, generic drug prices decreased 66%. Generic drugs saved the U.S healthcare system roughly $1.8 trillion in the last decade.
Drug shortages can occur because of three categories of challenges:
- Manufacturing / Regulatory
- Market / Pricing Factors
- Unsound Public Policy Can Exacerbate Drug Shortages
Recommendations for State to Address Drug Shortages

Download Fact Sheet

Issues

Drug Shortages

Preliminary Recommendations for Addressing Drug Shortages

dgaugh — Tue, 27 Nov 2018 16:27:43 +0000

Preliminary Recommendations for Addressing Drug Shortagesdgaugh Tue, 11/27/2018 - 11:27

Generic and Biosimilars Approvals Are Only Half the Story

cdavis — Wed, 10 Oct 2018 14:45:33 +0000

Generic and Biosimilars Approvals Are Only Half the Storycdavis Wed, 10/10/2018 - 10:45

FDA Approvals: Good News for Patients, More Work to Do (Part 2)

dgaugh — Thu, 10 May 2018 14:35:00 +0000

FDA Approvals: Good News for Patients, More Work to Do (Part 2)dgaugh Thu, 05/10/2018 - 10:35