Health Care

What happens in Washington influences biotechnology progress every bit as much as what happens on Wall Street or in the lab.

Thirty six thousand Americans die from seasonal flu each year, now there is additional threat a possible global avian flu pandemic.

Has a member of your family been vaccinated against hepatitis B? Do you know someone who has diabetes? Has anyone in your family had heart disease?

The public has a strong interest in protecting research and research participants. Federal policy must find the right balance in protecting participants while allowing critical research to continue.

Providers and policy makers must collectively address the profound effect the red-tape hassle can have on the practice of oncology.

Rx Drug Importation Poses Immediate and Incalculable Risk to American Patients (Apr. 19, 2004)

The Medicare conference agreement conforms closely to BIO's principles, and the association urges Congress to act quickly and send the bill to the White House for the president's signature.

In the early weeks of the 108th Congress, two Senate bills, S. 54 and S. 7, were introduced that embrace the "Greater Access to Affordable Pharmaceuticals Act of 2003" (GAAP), formerly known in the 107th Congress as S. 812

How the industry can develop biodefense products.

In the wake of the September 11 terrorist attacks, BIO surveyed the industry and found that many biotech companies were already working on defense projects or developing technologies useful for both conventional health care and for defense against biological, chemical and radiological/nuclear agents.

To Promote Public Health and National Security and to Fight Against Bioterrorism

Biotechnology tools and techniques open new research avenues for discovering how healthy bodies work and what goes wrong when problems arise.

Letters, Testimony & Comments

November 24 2015
In general, BIO is supportive of FDA’s effort to modernize regulatory oversight of drug quality and promotion of post-approval improvements, and of FDA’s quality metrics initiative overall. Assessing across organizations, programs, products, and processes can be a considerable challenge, and many factors, including where a particular product is in its lifecycle, may influence some measures. As a result, BIO is supportive of FDA’s intent to use the quality metrics gathered as a tool and in context with other sources of quality data and not as the sole way for FDA to determine the state of quality within sites or products. It would be helpful for FDA to more clearly state the intended use of the collected metrics and the benefits to industry. We understand that regulatory relief (e.g., less frequent inspections, post-approval manufacturing change categories) may be granted based on positive high-quality metrics; however, it is unclear whether FDA would use low-quality metrics as an indicator to increase inspections at a particular entity. We believe metrics can provide a valuable tool to quantify product quality and can assist the Agency in developing a risk-based inspection program. It will be important to view these metrics in their proper context and in the broader set of information and knowledge FDA possesses. BIO recommends that FDA clarify that the quality metrics data will be used as an input to the risk-based inspection model and for surveillance purposes only; FDA will not take compliance actions solely based on quality metrics data evaluation. In addition, BIO requests that clarity be provided regarding the extent to which CBER will implement this new approach for facilities it inspects.
July 10 2015
We applaud Chairman Fred Upton (R-MI), Ranking Member Frank Pallone (D-NJ) and Congresswoman Diana DeGette’s (D-CO) efforts on H.R. 6., which takes important steps toward placing patients at the center of the drug development process, and we believe will help spur the development of therapies for the most prevalent conditions, as well as encourage development of treatments focused on rare conditions and other unmet medical needs. We strongly support establishing a framework for incorporating patient views into the development and regulatory review processes in a more structured and transparent way, both with respect to patient input for benefit-risk assessments and use of patient experience data in regulatory decision-making.
June 5 2015
BIO submitted a letter to members of the Senate Judiciary Committee regarding the Managers Amendment to PATENT Act.
June 4 2015
BIO submitted a letter to members of the Senate Judiciary Committee regarding the Managers Amendment to PATENT Act.
February 23 2015
The Biotechnology Industry Organization (BIO) thanks you for the opportunity to provide our initial thoughts on your report Innovation for Healthier Americans. BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products.

Press Releases

December 1 2015
Bill would extend a cost-saving JOBS Act provision
November 18 2015
BIO released a list of seven proposed topics for the November 20th U.S. Department of Health and Human Services (HHS) Forum on Pharmaceutical Innovation, Access, Affordability and Better Health. The consideration of these topics at the Forum will help to ensure that patients have access to the most innovative new treatments and cures.