Act to end Manipulative Practices

Published June 6, 2018

Pass the CREATES Act to End Manipulative Practices that Cost our Patients Billions

By: Jeff Watson, Board Chair, Association for Accessible Medicines (AAM) and President & COO, Apotex Inc.

Since Apotex’s inception over 40 years ago, our company has focused on a sole purpose: improving access to affordable, innovative and high-quality medications. Over the years, we have seen the generics industry weather a number of challenges caused by legislative and regulatory changes in the markets in which we operate. The industry has also benefited from a number of positive changes that improve the ability of companies like Apotex to bring affordable generics and biosimilars to market – saving patients billions of dollars.

One such example of positive change came over 30 years ago with the passing of the Hatch-Waxman Act in the United States. This legislation established the modern day generic drug approval process, striking a finely-tuned balance between spurring the development of new medicines and ensuring timely access for the public to quality, affordable generic pharmaceuticals. This landmark piece of legislation has proved to be one of the most successful pieces of consumer legislation in history. Over the last 10 years alone, generic drugs have saved the U.S health care system $1.67 trillion.

Unfortunately, generic drug companies are currently facing a major headwind that is undermining the Hatch-Waxman Act’s goal of ensuring timely access to affordable generic medicines. Some brand drug makers are undermining the Act by using United States federal regulations or novel contract schemes to forestall generic competition. Brand drug companies do this by restricting our ability to purchase samples of their product which is required to support a generic application for FDA-approval. This anti-competitive practice costs patients more than $5 billion USD each year, putting medication out of reach for millions.

This problem is having a growing impact on the generic industry, taxpayers, and the patients we serve. Essentially, if companies like Apotex can’t purchase samples, we cannot introduce affordable, life-saving generic versions of expensive brand drugs into the market as intended by the Hatch-Waxman Act. This practice negatively impacts patients, the ability of the generic industry to deliver the savings on which the public relies, and the economic health of the generic industry as a whole.

The good news is that we have an opportunity to enact the change needed to end this costly gamesmanship; the solution is known as the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act. Supported by more than 60 organizations representing patients, providers, consumer groups and interest groups throughout the US political spectrum, the CREATES Act will establish an efficient, tailored path for generic drug and biosimilar manufacturers to acquire the samples needed for drug development.

In spite of industry challenges we will always continue to live out our purpose at Apotex. However, we can’t let the opportunity to tackle this problem pass us by. We strongly urge Congress to pass CREATES to allow a steady pipeline of affordable generics. To learn more about how you can get involved in supporting the CREATES Act, visit the Association for Accessible Medications.

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