Articles

On July 23rd, the House passed by voice vote an amendment on human patenting offered by Dave Weldon (R-Fla.) as part of the Commerce-Justice-State appropriations bill (H.R. 2799).

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

On October 24th the FDA published proposed regulations that affect implementation of the Hatch-Waxman law. These changes in part respond to recommendations in a July 2002 Federal Trade Commission (FTC) report and a Citizen Petition filed with the FDA by the FTC in May 2001.

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.

Last week, the Senate Health, Education, Labor and Pensions (HELP) Committee marked-up legislation - The Edwards/Collins substitute to S. 812 - The "Greater Access to Affordable Pharmaceuticals Act of 2001" - that raises serious concerns for members of the Biotechnology Industry Organization (BIO).

BIO-IES urges national representatives of the United States and other nations to seek inclusion of specific references to industrial and environmental biotechnology in the implementation program resulting from the Johannesburg Summit, including national action plans.

The Earth Summit at Rio de Janeiro in 1992 established a vision of "Sustainable Development." Where development historically was based almost entirely on economic calculations, there would now be an environmental component as well.

HHS Addresses Many of BIO's Concerns In Proposing Changes to the HIPAA Privacy Regulation

"Some History Should be Repeated," by Carl B. Feldbaum, Science, Feb. 8, 2002. An excerpt appears below.

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

The Biotechnology Industry Organization (BIO), in anticipation of possible debates on the changes to the Medicare reimbursement formula for currently covered drugs, has developed the following principles for consideration of various proposals. While we acknowledge that the current formula "Average Wholesale Price" (AWP) minus five percent may be changed, BIO urges Members of Congress to carefully consider the potential effects of various proposed changes to AWP on the quality of patient care and access to biotechnology products.

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

As people age they walk a minefield of life-threatening and debilitating diseases.

Position of the Biotechnology Industry Organization (BIO), regarding oversight of gene therapy

With the increasing computerization of medical records and the consolidation of the health care system, people have become more concerned about the potential threat to the confidentiality of individual health information.

BIO’s Mission is to be the champion for biotechnology. We advocate for policies that will enable the realization of biotechnology’s promise for providing breakthrough products to cure disease, protecting against bio-terrorism, feeding the hungry, and cleaning our environment.

BIO supports the creation of federal standards to protect the confidentiality of an individual's medical information, including the results of genetic testing.

The Biotechnology Industry Organization (BIO) supports national legislation to protect the confidentiality of all individually identifiable medical information. BIO believes that this medical information must be respected, treated confidentially and safeguarded from discriminatory misuse.

BIO is the world's largest biotechnology organization, providing advocacy, business development and communications services for more than 1,100 members worldwide.