Author Archive: Tracy Cooley

Tracy Cooley

Tracy serves as the Director of Events Communications and handles all communications for BIO’s events and emerging company policy issues. She loves blogging and podcasting on all things biotech and believes in the great potential of the industry, looking for every opportunity to spread the message far and wide. Nearly everyone in her family is a golfer, and as such, she has what many people have called a “natural” swing. Sometimes she even hits the ball. Tracy just finished her ninth marathon, and has nearly mastered the skill of one-foot-in-front-of-the-other (usually, sometimes the laces get in the way). The joy of her life is her five-year-old daughter Josephine.

Latest Posts

IPAB: Bad Medicine for Patient Care

DC in Fall

The Independent Payment Advisory Board is bad medicine for patient care, deficit reduction and containing Medicare costs. This board, consisting of 15 bureaucrats appointed by the President, has been given the power to make decisions affecting patients’ quality of care, with almost no oversight and no means for challenging its decisions. IPAB must be repealed. There is widespread support among patient advocacy groups and members of Congress on both sides of the aisle for full Read More >

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The Hill’s Congress Blog: Innovation in medicine isn’t optional – it’s imperative

TheHill

Earlier this week, The Hill’s Congress Blog posted an op-ed penned by Andrew von Eschenbach and Paul Howard entitled, “Innovation in medicine isn’t optional – it’s imperative” highlighting the importance of encouraging innovation and preserving incentives for drug development. The authors recommend increased cooperation and collaboration between industry, academia, and regulators, in addition to recognition by the federal government that ‘a vibrant life-sciences industry will generate higher national productivity, lower total health care costs, and Read More >

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Congress Passes Omnibus Spending Agreement

Jim Greenwood

This week, BIO President and CEO Jim Greenwood praised the Congress for passing the fundingbill for fiscal 2014, which would, among other things, allow the Food and Drug Administration (FDA) to access $85 million in user fees sequestered in 2013. In addition, BIO supports the agreement’s overall funding for: FDA, NIH, the biodefense enterprise; and improved program oversight of the important 340B program.  BIO also strongly supports the language in the bill providing the Department Read More >

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Emerging Company Policy Deconstructed: Fostering Innovation Act (H.R. 2629)

scientists115x76

In a nutshell: Representative Michael Fitzpatrick (R-PA) introduced H.R. 2629, the Fostering Innovation Act, to update SEC filing status classifications for public companies and help ease regulatory burdens on emerging companies and reduce the bureaucratic hurdles and red tape that lengthen the time to bring cures from discovery to patient. Why you should care: SEC Rule 12b-2 establishes three classifications for public companies to determine their filing status, which include large accelerated filers (companies with Read More >

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National Traceability System Moves into Implementation

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Last week, President Obama signed into law the Drug Quality and Security Act (H.R. 3204), which created a single, uniform and national solution to safeguard the nation’s pharmaceutical supply chain against criminal counterfeiting. Inside Health Policy’s Alaina Busch highlighted implementation plans in this November 20 story, “Drug Security Bill Ushers In Compounder Market Shift, 10-Year Effort To Implement Rx Tracing,” which can be accessed here with a subscription. Below are details on implementation based on Read More >

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