BIO Year by Year

1993

• The Biotechnology Industry Organization (BIO) is created through the merger of the Industrial Biotechnology Association and the Association of Biotechnology Companies.
• President Bill Clinton takes office, with health-care reform, including consideration of price controls, high on his agenda. BIO Chairman Kirk Raab speaks at the White House Health Care Reform Task Force's drug price control working group, and other company CEOs and BIO staff ("SWAT teams") meet throughout the year with health-care reformers in the Clinton administration, including the president himself, blasting them with the message that price controls would hurt the industry. Proposals under consideration include a Breakthrough Drugs Committee that would have the power to publicly reprimand companies whose prices are deemed excessive, and potentially to deny such companies the R&D tax credit, Medicare/Medicaid reimbursement, or full patent terms. With price controls on the table, stock prices for biotech companies plunge 40 percent.
• Bovine somatotropin-bovine growth hormone-is approved, and legislation is introduced to mandate labeling. BIO testifies against these proposals. There is scattered opposition to such products, but the FDA and other regulatory agencies stand by their scientific approach to regulation.
• FDA declares that genetically engineered foods are not "inherently dangerous" and do not require special regulation.
• Congress passes legislation that provides a 50 percent capital gains exemption on investments held at least five years in companies valued at $50 million or less. The measure is a welcome step toward a tax code that better reflects the risk of biotech investment, but the capitalization requirements are deemed too low.

1994

• The threat of drug price controls in the Clinton health-care plan spooks investors and dampens biotech stock prices through most of the year. BIO leaders pull out every stop-visits to Capitol Hill, calls, letters, discussions with administration health-care reformers and reporters and editors covering the issue, testimony at hearings, op-eds-to apprise the nation's political leadership of the devastation price controls would wreak on innovation. Arid capital markets for biotech during this period of uncertainty illustrate the point vividly. BIO's efforts pay off, however, and by late 1994 price control measures are abandoned.
• Preoccupied with partisan firefights over the federal budget and the broader Clinton agenda, Congress allows the orphan drug research tax credit to lapse at the end of 1994.
• The General Agreement on Trade and Tariffs (GATT) is approved, changing the length of time patented products enjoy marketing exclusivity in the United States. In the past, the exclusivity period was 17 years from the date of issuance; under GATT, it is 20 years from the date of filing. The net result is a loss of patent term for most biotech patents due to their complexity.

1995

• With the Clinton health-care reform package deep-sixed and an anti-regulation Republican majority in Congress, BIO turns its attention squarely to FDA reform, an effort that will culminate in the 1997 passage of the FDA Modernization Act (FDAMA). Many Washington, D.C.-based policy groups join BIO in the call for reform. BIO Chairman and Genzyme CEO Henri Termeer leads the effort alongside Gordon Binder, CEO of Amgen and head of BIO's FDA Reform Task Force. By November, BIO has worked with Vice President Al Gore (through his Reinventing Government program) and leaders at the FDA to eliminate two regulatory hurdles: the establishment licensing application, which required firms to obtain approval of drug manufacturing facilities separate from approval of the product candidate itself; and lot-lease approvals, a process of continuous review of each production lot of a drug following approval. BIO seeks to codify these administrative changes and to expand the scope of FDA reform.
• President Clinton establishes the National Bioethics Advisory Commission (NBAC) in an executive order that also calls for a review of policies and procedures surrounding human subjects research, the use of genetic information, and gene patenting. BIO is granted a nomination and selects Steven Holtzman, chief business officer at Millennium Pharmaceuticals.
• The U.S. Patent Office agrees to allow applicants to meet utility requirements by submitting scientific evidence from preclinical research rather than clinical trials. Also, a law is passed that eases the requirements for process patents covering manufacturing and allows enforcement of such patents against imported products.

1996

• Congress reauthorizes for one year the orphan drug tax credit after an 18-month lapse and permits companies to carry forward and carry back the credit, which covers 50 percent of the cost of clinical trials for orphan drugs. The carry-forward provision allows companies not yet profitable-and hence owing no taxes-to use the credit when they become profitable.
• BIO lends its support to passage of the Health Insurance Portability and Accountability Act, which prohibits insurance companies from denying coverage based on pre-existing conditions when people change insurers through job changes. The original bill treats genetic information separately from other types of medical information, but BIO urges lawmakers to apply "the same standards of confidentiality and nondiscrimination for all personal medical information, whether it is gathered using genetic tests or any other diagnostic process." In the end, the bill includes genetic information in the definition of medical information.
• Genetic privacy is also a hot issue on the Hill and with the NBAC, which meets for the first time. BIO calls for federal standards to protect all medical information, including genetic data.
• Several bills are proposed to reform the FDA, including one that would turn drug applications over to private reviewers if the agency fails to render a decision after six months. In the turbulent atmosphere of a presidential election year, even the idea of privatizing the FDA is floated (a move BIO does not support). The disparate efforts keep the issue front and center but in the end do not result in legislation. Meanwhile, negotiations begin in earnest for renewal of the Prescription Drug User Fee Act, set to expire in 1997. The negotiations are complicated by the resignation of FDA Commissioner David Kessler, who opts to return to private life after six years at the agency. It will be more than a year before Jane Henney is named as the new commissioner.

1997

• Dolly, the first-ever mammalian cloning achieved via somatic-cell nuclear transfer, is unveiled in late February, dramatically raising awareness-and scrutiny-of the industry. BIO immediately issues a statement opposing application of the technology to reproductive cloning of human beings. The Public Relations Society of America later gives BIO an award for excellence in crisis management.
• Congress and state legislatures respond to Dolly with hearings on human cloning and bills to ban the technology; some measures would ban all applications of human cloning, pulling legitimate research into the dragnet, while others target reproductive cloning. President Clinton proposes a reproductive cloning ban with civil penalties based on NBAC recommendations. Congress adjourns without taking any action.
• The orphan drug tax credit is made permanent. In addition, a new federal law is passed that allows early-stage investors in entrepreneurial businesses, including biotechnology companies, to exclude from capital gains taxation 50 percent of the gains from such investments, if held for five years.
• FDAMA is signed into law, codifying administrative changes begun in 1995 and introducing new reforms. The law marks the most substantial reform of the agency in three decades. Provisions include the following:
  • Criteria for fast-track drug development.
  • Drug approvals allowed based on one pivotal trial.
  • Codification of FDA reforms implemented under Vice President Al Gore's Reinventing Government initiative.
  • Easier patient access to experimental drugs and medical devices, and an accessible database of clinical trials.
  • An end to the prohibition on manufacturer dissemination of peer-reviewed journal articles describing trials of off-label uses.
  FDAMA includes a reauthorization of PDUFA, which allowed the FDA to cut the average drug review time in half over five years by charging companies fees in exchange for guaranteed review periods.
• BIO membership passes the 700 mark.

1998

• A Chicago scientist named Richard Seed announces plans in January to clone a human being. BIO responds with a statement reiterating its position that such a procedure is unsafe and raises ethical questions that have yet to be addressed. When Congress reconvenes, House and Senate majority leaders say cloning tops their agenda. The Senate considers, and rejects, legislation that would ban human cloning, including therapeutic applications of the technology. BIO is joined in its opposition by 27 Nobel Prize winners and a multitude of scientific research and patient advocacy groups. No legislation passes at the federal level.
• BIO, along with nearly 200 patient and health groups, calls for the doubling of the $13.6 billion NIH budget in five years. Congress is receptive, and by 2003 the NIHbudget tops $27 billion.
• Researchers at the University of Wisconsin isolate human embryonic stem cells. In a BIO statement, President Carl Feldbaum praises the work, but notes that "these research achievements raise bioethical questions that require thorough and open national discussion …These are issues that, in some instances, involve sincerely held social and religious beliefs and perspectives." BIO calls on NBAC to review the ethical issues and make recommendations to President Clinton based on that review.
• BIO membership passes the 800 mark.

1999

• Mark Skaletsky is named BIO chairman, marking the first time the organization has been led by an executive at a small or midsized biotech firm. BIO's previous chairs were CEOs of the largest companies in the industry-Genentech, Genzyme and Amgen.
• BIO hosts its first CEO and Investor Conference in New York. Fifty-four CEOs make business presentations to an audience of 800 analysts, investors and other industry observers. The successful conference becomes part of BIO's annual lineup of events.
• A letter published in Nature about the effects of pollen from Bt corn (corn genetically modified to express a pesticidal protein) on monarch butterflies sparks a media frenzy and heightened regulatory and public scrutiny of genetically modified crops in the United States and elsewhere. Later in the year, preliminary field studies fail to document the effect under real-world conditions.
• The National Center for Food and Agricultural Policy releases the first-ever analysis of biotechnology's impact on crop protection and benefits to the environment, finding significant increases in crop yield, reductions in farming inputs such as pesticides, and a shift to farming practices promoting integrated pest management and conservation tillage.
• Price control worries are revived as President Clinton and Congress explore various proposals to provide Medicare coverage of outpatient prescription drugs. In a Rose Garden speech, Clinton calls for voluntary coverage under which Medicare would pay half the cost of prescription drugs up to $5,000. BIO calls many aspects of the plan "laudable," particularly its stated intent to use free-market mechanisms, but laments the absence of stop-loss coverage for seniors with the highest prescription drug costs. BIO's board of directors adopts six principles that a plan must include to win the organization's support:
  • Reliance on private markets and competition with no price controls.
  • Stop-loss protection and protection of those most in need first.
  • Expansion of beneficiary choices among private plans.
  • Incentives for improved patient care through biotechnology innovations.
  • Continuing Medicare solvency.
  • Doing no harm to current coverage and reimbursement.
• In the late spring of 1999, Wall Street indifference to biotechnology morphs into exuberance as genomics catches the imagination of investors amid a hot race between public and private entities to complete the sequencing of the human genome. The Nasdaq Biotech Index doubles over the course of the year, and investment in new offerings soars in the fourth quarter.
• The Recombinant DNA Advisory Committee at the NIH examines the gene therapy clinical trials program at the University of Pennsylvania following the death of 18-year-old patient Jesse Gelsinger in a trial of a therapy for a rare metabolic disorder.

2000

• A skyrocketing market for biotech stocks falls to earth when mid-March comments by President Clinton and British Prime Minister Tony Blair are widely misinterpreted as advocating restrictions on gene patents (the comments concerned keeping the human genome sequence in the public domain, a different matter). Nonetheless, the year generates a record $38 billion in new biotechnology investment, including 90 completed initial public offerings, also a record.
• In June, the Human Genome Project and Celera Genomics jointly announce the completion of a rough-draft sequence of the human genome.
• A new law is passed that increases the annual limit on H-1B work visas for skilled professionals to 195,000 over three years and exempts from the cap university and related research faculty employees. Some 15,000 biotechnology employees (almost 10 percent of the industry's work force) have H-1B visas.
• BIO launches its first TV campaign with "Biotechnology: A Big Word That Means Hope."
• BIO publishes a white paper called Biotechnology's Impact on Diseases of the Elderly. The study highlights biotechnology medications in development or on the market to treat eight of the most common diseases and disabilities associated with aging: coronary heart disease, stroke, cancer, Alzheimer's and Parkinson's diseases, chronic renal failure, diabetes mellitus and osteoporosis. The study notes that, in addition to improving quality of life, some of 20 marketed drugs targeting these diseases save money by reducing hospitalizations, doctor visits and outpatient procedures.
• BIO publishes a report called Economic Contributions of the Biotechnology Industry to the U.S. Economy. The report finds that in 1999, the biotech industry generated 437,000 jobs and $11 billion in research and development spending.
• The BIO Editors' and Reporters' Guide wins an American Society of Association Executives Award for Excellence.
• BIO membership tops 900; all 50 states are now represented.
• Prescription drug coverage under Medicare becomes a hot issue in the presidential campaign, with both candidates promoting plans. In letters and statements, BIO urges the candidates to tell the voters "not only how their plans will help seniors gain access to prescription drugs, but also how those plans will encourage innovative drug development to improve the health and quality of life of seniors."
• The Environmental Protection Agency (EPA)reaffirms that a review of all available scientific information indicates that monarch butterflies are at very little risk from Bt corn products. The EPA finds that widespread cultivation of Bt crops benefits the environment.
• Food producers begin a massive recall of corn products when taco shells are found to contain traces of StarLink corn, a corn variety approved for animal feeds but not for human consumption. Regulatory agencies subsequently end the practice of so-called split approvals.
• In August, NIH releases funding guidelines for human embryonic stem cell research. Guidelines allow funding for work performed with the cells, but not for the derivation of the cells. No grants are ever provided under the guidelines, which are put on hold when President Bush takes office in 2001.
• A BIO survey finds that 270 million patients have been helped by biotechnology since the industry's inception.
• BIO testifies at a public hearing on reauthorization of the PDUFA, which runs through 2002. The three concerns expressed are the need for a more predictable review process that includes better communications and more timely interaction with FDA reviewers; FDA's unwillingness to agree to protocol specifications in writing; and slow, "indeed glacial," implementation of FDAMA provisions designed to guide companies in the dissemination of information about cost-effectiveness and off-label uses of drugs.

2001

• NIH stem cell funding guidelines are put on hold for re-evaluation when President Bush takes office. After months of rancorous debate and escalating media coverage, Bush addresses the country on prime-time television August 9. His decision: to fund research on stem cell lines already established, which he says number 60. BIO supports the decision, but takes issue with the limitation on stem cell lines, as do many scientists and patient groups.
• Moves to reform the clinical trial process kick into high gear, with NBAC issuing new recommendations and the Senate conducting hearings. Among other things, the NBAC proposal calls for legislation that would make all clinical trials subject to the same oversight as those that receive federal funding. Clinical trial rules would also be made more consistent across state lines, a move BIO endorses. BIO has harsh words, however, for an FDA proposal that would require disclosure of investigational new drug applications for gene therapy and xenotransplantation trials, calling the concept "fatally defective." BIO files comments arguing that it would be unfair to single out these two therapeutic approaches in a reversal of long-standing FDA policy against disclosing trade secrets about medical products during their development.
• President Bush creates a new council on bioethics, to be headed by University of Chicago professor Leon Kass.
• The House of Representatives passes a bill that would ban all applications of human somatic cell nuclear transfer (cloning), including therapeutic applications. BIO opposes the measure, arguing that a ban should be limited to reproductive cloning. Debate dovetails with the controversy over stem cell research and is further inflamed when offshore scientists tell a National Academy of Sciences panel they can and will conduct reproductive cloning experiments.
• BIO membership passes the 1,000 mark.

2002

• In June, Congress renews PDUFA, which increases FDA resources for drug and biologics reviews and incorporates BIO recommendations designed to improve first-cycle product reviews and engage third-party expert advisors on cutting-edge scientific issues.
• In the late summer and fall, the FDA moves to revise good manufacturing practices and consolidate reviews of pharmaceuticals, including therapeutic biologics, at the Center for Drug Evaluation and Research. BIO works with the FDA in effecting the therapeutic biologics move in a manner least disruptive to drug development and review.
• BIO succeeds in persuading the Health and Human Services Department to modify medical records rules that would have inhibited research. The new rules allow for use of de-identified information in medical research.
• BIO launches a global health initiative, aimed at forging new partnerships to apply biotechnology to diseases of the developing world. The Partnering for Global Health Forum in December attracts almost 400 representatives of the industry, government and international agencies, nongovernmental organizations and the financial community.
• The one-year anniversary of President Bush's decision to partially fund stem cell research is marked by criticism of the policy. Few of the promised stem cell lines are actually available.
• The Homeland Security Act incor-porates BIO-supported liability protections for biotech companies developing countermeasures against possible terrorist attacks.
• The Farm Security and Rural Investment Act of 2002 includes pro-biotech measures such as significantly increased funding for research and risk assessment, and new programs for promoting biotechnology in developing countries.
• In late November, the Securities and Exchange Commission proposes a rule recommended by BIO that would allow biotechnology companies greater investment flexibility.
• BIO wages an aggressive and successful campaign to defeat the Greater Access to Affordable Pharmaceuticals Act (S. 812), which would have significantly weakened patent protections for biopharmaceutical companies.
• BIO and its allies among patient and scientific groups prevent Congress from adopting a total ban on cloning, including therapeutic applications. BIO supports a more limited ban on reproductive applications of the technology.
• BIO and its members develop policies for the safe development of plant-made pharmaceuticals as media coverage of this new technology heats up.

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