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The Presidential Inaugural: Looking Back at 30 Years of Biotech Policy Milestones

January 18, 2013
As President Barack Obama prepares for his second inauguration, we decided that it would be a good time to take a look back on some of the most important pieces of legislation enacted by past presidential administrations and Congress with the support of the biotechnology industry.

From helping create jobs, to propelling continued innovation and promoting research to find cures for rare diseases, the following pieces of legislation from the past 30 years are some of the greatest examples of an industry and government working together to make sound policy.

President Barack Obama (First Term 2009 – 2013)

Jumpstart Our Business Startups (JOBS) Act  (2012)
President Obama signed the Jumpstart Our Business Startups (JOBS) Act into law on April 5, 2012. BIO advocated strongly for this new law, which included several important policies designed to stimulate capital formation for growing businesses – including those in the biotech industry.

Food and Drug Administration Safety and Innovation Act (FDASIA) (2012)
The legislation enhanced the development and review of innovative new therapies through increased transparency and scientific dialogue, advancements in regulatory science and strengthened post-market review. It also reauthorized the Prescription Drug User Fee Act (see below) and increased the Food and Drug Administration’s (FDA) access to external expertise to improve the drug review process.

President George W. Bush (2001 – 2009)

Energy Policy Act (2005)
The Energy Policy Act improved domestic energy security by setting goals for production of renewable fuels made from U.S. agricultural resources. In addition, the act authorized $3.6 billion in funding for bioenergy and biobased products.

Medicare Prescription Drug and Modernization Act (2003)
Because seniors and disabled patients comprise a majority of those treated with biotechnology medicines, BIO supported the expansion of Medicare coverage to include prescription drugs. The landmark legislation ensures that the patients who need biotechnology medicines the most have access to them.

President William Jefferson Clinton (1993-2001)

The Food and Drug Administration Modernization Act (1997)
FDAMA codified administrative changes that had begun in 1995 and introduced new reforms. Provisions included criteria for fast-track drug development, easier patient access to experimental drugs and medical devices, and an online database of clinical trials.

President George H.W. Bush (1989-1993)

Prescription Drug User Fee Act (1992)
PDUFA instituted fees for drug approval applicants that provide the FDA with resources to review products faster. The successful program has been reauthorized in 1997, 2002, 2007, and now, with FDASIA 2012.

President Ronald  Reagan (1981-1989)

Orphan Drug Act (1983)
The Orphan Drug act created new incentives to conduct R&D on therapies for rare diseases. About 250 FDA-approved therapies for orphan diseases have reached the U.S. market.

We congratulate President Obama on his re-election as president of the United States and stand ready to work with him to build on our past success and tackle some of the greatest challenges of our time.