Biotech bio-tech
sort of an orphan category, refers more to pharma than gmo? distinction seems lost/muddy, so this will be industry trade/front groups like BIO
BALLROOM?
SEE LONSDALE KOCH FUCKERY FDA RFK2?
sludge
Billionaire Pharma Investors Fund Privatized 'Strike Team' at the FDA
By David Moore
Published on Jul 9, 2025
Venture capitalist Joe Lonsdale, a close ally of Elon Musk who announced the project, and his Koch network funding partner each have extensive investments in healthcare startups subject to FDA regulations.
On Monday, venture capitalist Joe Lonsdale, a prominent Trump supporter and Elon Musk confidante who has extensive investments in health care startups, announced that he is funding an initiative inside the Food and Drug Administration that he says will “upend America's health bureaucracy” and enable faster approval of cures. His announcement comes after the Trump administration cut thousands of FDA jobs this year, as Musk’s DOGE team slashed capacity at federal agencies under a Trump executive order.
While Lonsdale describes the project’s mission as ensuring the U.S. does not fall behind China in biotech advances and patient outcomes, his portfolio is set up to profit from an overhaul at the FDA. The initiative he unveiled will embed personnel who he funds to “sit desk‑to‑desk with reviewers” at the FDA—with more significant funding from libertarian billionaire Charles Koch.
Lonsdale’s firm 8VC lists investments in dozens of life sciences and biotech companies, including startups developing personalized treatments, products in areas like microbiomes, and gene therapies using the CRISPR technology. Many of the companies have business before the FDA and could benefit from being advanced by friendly reviewers. For example, the 8VC portfolio company Cellino Bio recently announced it had received an FDA designation as an Advanced Manufacturing Technology, and portfolio company Synthego published a post in April discussing FDA guidance documents.
Lonsdale’s blog post said that the Utah-based Abundance Institute, a new nonprofit closely tied to a Charles Koch-funded academic center, will partner with the Koch network’s gigantic “dark money” group Stand Together to raise $4 million for the project. Koch Disruptive Technologies, the venture capital arm of Koch Industries, also lists more than a dozen healthcare startups in its portfolio developing AI-powered cell research, gene therapies, and other machine-learning data plays.
The money will be used “to place a strike team of 15-20 AI-native software engineers, data scientists, and product leaders inside the FDA to accelerate the FDA's latest AI initiatives and bring outsider perspectives on new areas to iterate on fast,” Lonsdale wrote. The new personnel will “wire modern data pipes into legacy silos,” among other things. Lonsdale wrote on X that he and his friends, whom he left unnamed, were donating to launch the project and that he will personally be sponsoring one of its engineers.
SOUNDS DOGE-Y
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AN 12 25
After President Donald Trump returned to the White House on January 20, his administration aggressively downsized a long list of federal government agencies with the help of the Department of Government Efficiency (DOGE) and its then-leader, Tesla/SpaceX/X.com head Elon Musk. Trump claimed that his goal was reducing "waste, fraud and abuse," but critics of the Trump Administration/DOGE cuts argued that they were robbing the agencies of crucial personnel they need in order to function properly — from the U.S. Social Security Administration (SSA) to the National Weather Service (NWS) to the Internal Revenue Service (IRS).
Another agency that has been suffering chaos during Trump's second presidency is the U.S. Food and Drug Administration (FDA).
In an article published on December 4, Axios' Pete Sullivan describes the FDA departures that are contributing to instability at the agency.
"Another abrupt departure of a high-ranking Food and Drug Administration official is raising alarm about a brain drain that could mean new drugs take longer to reach the public," Sullivan reports. "Why it matters: Biotech and pharmaceutical companies rely on the FDA for dependable guidance as they spend huge sums developing new treatments. The American public needs the agency to ensure treatments are safe and effective…. Driving the news: The latest uproar surrounds the unexpected departure of Richard Pazdur, a respected oncologist who just three weeks ago became the fourth person to direct the FDA's drug center this year."
Sullivan adds, "Pazdur's appointment had helped calm nerves to some degree within industry after months of turmoil. But now, executives and even former FDA commissioners are publicly questioning the agency's direction."
One of the people who is sounding the alarm about the FDA is Biotechnology Innovation Organization CEO John Crowley.
Crowley told Axios, "This constant turmoil is undermining America's leadership in biotechnology, creating unprecedented regulatory instability and unpredictability, and risks ceding this critical sector to China."
According to Sullivan, "morale" has "plummeted" at the FDA.
A former FDA staffer, interviewed on condition of anonymity, told Axios, "They don't talk to each other. They go to the bathroom, they come (back), they shut their door."
*Read Peter Sullivan's full article for Axios is available at this link.
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https://www.alternet.org/2020/03/we-already-paid-for-covid-19-treatments-we-cannot-let-gilead-make-us-pay-again
no lnx
We already paid for COVID-19 treatments — we cannot let Gilead make us pay again
Written by Alex Lawson / Independent Media Institute March 26, 2020
Update, March 25, 2:45 p.m.: Gilead has renounced the benefits of orphan designation, but still retains other patents that give them a five-year monopoly on remdesivir.
There’s much we don’t yet know about COVID-19, the disease caused by the novel coronavirus. We don’t know how long the pandemic will last, when a vaccine will be developed, or how many lives antiviral medications can save. But there’s one thing we know for sure: U.S. taxpayers have already paid for the research and testing of the most promising treatments.
These treatments should be available to everyone who needs them at no cost. But the Trump administration’s drug policy is led by two former pharmaceutical executives, and that is having devastating consequences for potential access to treatments and vaccines for the COVID-19 pandemic.
If you’ve been watching Donald Trump’s daily press briefings, that might come as a surprise. During his 2016 campaign, Trump loved to talk tough on pharma and say he would fight for lower drug prices. But then he put Alex Azar, a big pharma CEO infamous for doubling the price of insulin, in charge of regulating health care. Several weeks ago, Azar refused to guarantee that a coronavirus vaccine will be affordable for all, citing the need to protect big pharma’s profits.
Azar is now a member of Trump’s coronavirus task force, and his influence is evident during the briefings. Over and over again, Trump talks up big pharma corporations and thanks them for their work on COVID-19 treatments and a potential vaccine. He refers to them as “great companies” and their executives as “geniuses.”
trump fails to mention that taxpayers have spent nearly $700 million on coronavirus research through the National Institutes of Health (NIH). Nor does he mention that big pharma corporations spend more money enriching themselves through stock buybacks than they do on research and development.
One medication currently being tested on coronavirus patients is the antiviral remdesivir. It’s still too early to say if remdesivir will prove broadly effective at helping patients with COVID-19. But if it does end up being a major part of treating the disease, it’s essential to remember who paid for the drug’s development: The American people.
Remdesivir was developed with research funded by a $37.5 million NIH grant. The NIH plans to spend at least an additional $30 million on phase II trials of the medication this year. Since we’ve all paid for remdesivir’s development through our taxpayer dollars, it should be available to everyone who needs it at no cost.
Instead, the Trump administration just granted Gilead, a giant pharmaceutical corporation, “orphan” drug status for remdesivir. That means that Gilead is free to charge outrageous prices for the drug, with their government-granted exclusivity ensuring that there will be no competition for years to come.
What makes this even more outrageous is that orphan status is designed to incentivize research and development of treatments for rare diseases. A pandemic is the opposite of rare!
We don’t know what role Joe Grogan, Gilead’s former chief lobbyist, and currently the director of Trump’s domestic policy council, played in this decision. But it seems a safe bet that such an outrageous move to profit off a pandemic had to have support from the top.
Nor is remdesivir an outlier. This is how all new medications work.Taxpayers always fund the riskiest and most crucial research and development. Then, pharma gets the patent monopolies and uses them to charge outrageous prices. American families are going bankrupt paying four- and five-figure prices for drugs that their taxpayer dollars already paid to develop!
Politicians might be tempted by a short-term solution—requiring all COVID-19 treatments, as well as an eventual vaccine, to be low-cost or cost-free. But that doesn’t go far enough. It does nothing to help the Americans with diabetes who are dying every year because they are forced to ration their outrageously priced insulin. It does nothing for seniors, who will soon be spending half their hard-earned Social Security checks on health care costs. And it will do nothing to help patients when the next pandemic comes.
We need permanent structural changes. Fortunately, we know exactly what we need to do, and the American people agree with these changes across partisan lines:
when a drug corporation is abusing their patent privilege by charging outrageous prices, revoke the privilege and allow generic competition to drive down prices. This policy is supported by 78 percent of all voters and opposed by only 10 percent.
Allow public manufacturing of drugs to alleviate shortages and eliminate bottlenecks. This policy is supported by 70 percent of all voters and opposed by only 17 percent.
Increase taxpayer funding of research and development of vaccines and pharmaceuticals by creating a “full cycle” public R&D program with no patent monopolies and immediate generic production of the results. This policy is supported by 69 percent of voters and opposed by only 15 percent.
Donald Trump wasn’t prepared for the COVID-19 pandemic, but the public health community has been preparing for years. The research we’ve funded is going to be critical in the coming months. We’ve already paid for it. Let’s demand that Congress change the law so that we don’t have to pay again.
Alex Lawson is the executive director of Social Security Works, a non-profit advocacy group that supports expanding benefits to address America’s growing retirement security crisis. Lawson has appeared on numerous TV and radio outlets and is a frequent guest host of The Thom Hartmann Program, one of the top progressive radio shows in the country.
This article was produced by Economy for All, a project of the Independent Media Institute.
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University of California CRISPR researchers form drug discovery alliance with pharma giant
BY JON COHENJUN. 13, 2019
Top CRISPR researchers at two University of California (UC) campuses have teamed up with pharmaceutical giant GlaxoSmithKline (GSK) to form a new laboratory in San Francisco that will exploit the genome editor to screen for new drugs.
Drawing on a GSK commitment of $67 million over 5 years, UC Berkeley’s Jennifer Doudna, a co-inventor of the powerful CRISPR tool, and UC San Francisco’s Jonathan Weissman will select the academic talent to work in the new Laboratory for Genomics Research (LGR). “This is really, for us as academics, kind of a dream come true,” Doudna says.
Although Doudna has already co-founded two CRISPR-related companies and co-runs the Innovative Genomics Institute with Weissman, she says the LGR “takes the not very interesting parts of the screening efforts out of the picture.” A friend who visited her lab a few years ago described it as “artisanal,” she recalls and wondered why they weren’t using more automation. “It was a nice way of saying that it seems really fusty,” Doudna says. She hopes the LGR will allow them to use “genome editing and CRISPR, in particular, as a tool to understand the causes of disease in a way that had really never been possible in the past.”
Weissman, a physicist who morphed into a protein-folding specialist, specializes in using CRISPR to construct large-scale probes of gene functions. “We don’t have the capability, the knowledge, or the resources to develop drugs,” he says. “I’m trying to understand what are the problems that [GSK is] facing and what are the tools that would really solve the problem. As a tool builder, my biggest fear is we build a bridge to nowhere.”
In all, London-based GSK will fund 24 full-time UC researchers—only some of whom will come from Doudna’s and Weissman’s labs. GSK will contribute as many as 14 of its own employees. UC will own the intellectual property (IP) of any new tools invented in the lab, while GSK hopes to patent new drug targets. UC will receive a “financial benefit if a drug that requires licensed IP comes to market,” a GSK spokesperson says, noting that the exact terms are “confidential.”
Hal Barron, GSK’s chief scientific officer, says 90% of genes still have opaque functions. He hopes that by using CRISPR to knock out or turn on genes in cells and animal models, the LGR will be able to double the number of genes with known functions. “Think about the impact of that as being able to develop twice as many drugs,” Barron says.
Other academics who have had similar partnerships said they are useful, but can be tricky. “Overall, the model is great and the [CRISPR] space is ripe for innovation that’s not fundamental biology or chemistry but an engineering problem,” says UC San Francisco’s Jeffrey Bluestone, an immunologist who for the past 9 years has taken part in a collaboration between the school and Pfizer. The challenge, he says, is that there can be a “disconnect” when there’s a discovery about a potential drug that targets a disease not in the company’s portfolio.
The Harvard Stem Cell Institute took part in a collaboration with GSK between 2008 and 2013 to develop new drug targets for regenerative medicine. “It was a really great interaction,” says Harvard stem cell biologist David Scadden, who notes it ended because GSK got out of the regenerative medicine business. “Having academics who are bilingual in terms of understanding how companies have to think as they develop products is a good thing,” he says.
The lab, located at UC San Francisco’s Mission Bay campus, is already up and running.
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https://www.alternet.org/2019/05/how-donors-ended-up-fueling-an-unproven-and-dubious-2-billion-stem-cell-industry/
...For more than half a century, the regenerative possibilities of stem cells — which the body stores to repair damaged tissue and organs and restore blood supply — have tantalized the medical community. Bone marrow transplants for cancer patients, which rely on blood stem cells, fulfill this potential. But alongside legitimate, scientifically proven treatments, an industry has sprung up in which specialized clinics offer miracle remedies from poorly understood stem cell products.
These clinics are multiplying in the United States. According to a tally by Leigh Turner, an associate professor of bioethics at the University of Minnesota, there were 12 such clinics advertising to consumers in 2009; in 2017, there were more than 700. Unproven cellular therapies are a $2 billion global business, according to a recent paper co-authored by Massimo Dominici, the lead investigator at the cellular therapy lab at the University of Modena and Reggio Emilia, in Italy.
This burgeoning business is largely unregulated. Technically, manufacturers are required to submit stem cell therapies for review as a drug, and to provide evidence of their safety and efficacy, but the U.S. Food and Drug Administration hasn’t enforced the rule consistently. The former FDA commissioner Dr. Scott Gottlieb acknowledged in an interview that the agency’s laissez-faire attitude has made it easier for stem cell clinics to proliferate. “This is an example where the FDA, for a long period of time, took enforcement discretion, then the field grew,” he said. “Then it becomes hard to step in and actually apply the regulation.”
Many clinics offer stem cells taken from a patient’s own bone marrow or fat. But they’re being challenged by a newer technology: amniotic stem cells.
Greene’s company, R3 Stem Cell, was established in 2013. It distributes amniotic stem cells to about 30 clinics nationwide, which have administered them to 10,000 patients, according to an R3 brochure. It also handles marketing for the clinics. In an interview, Greene acknowledged that the benefits of amniotic stem cells that he touted at the Robson Ranch seminar are based on “a lot of success stories,” rather than on clinical trials. “I don’t claim anything,” he added. “I don’t claim that this is a treatment. I don’t claim that it cures anything. I don’t claim that it’s a permanent fix. All I discuss is maybe, potentially, people can get some improvements from stem cell care.”
One appeal of amniotic stem cell treatments is convenience. They don’t require patients to undergo liposuction or bone marrow extraction; instead, manufacturers harvest the cells from tissues donated by women who have recently given birth, and the cells are then frozen and shipped to clinics. There’s no special training needed to administer amniotic treatments, either — a nurse practitioner on staff can give injections — so chiropractors, beauticians and sports medicine doctors can enter the field with relative ease. A procedure such as an injection into a joint might take about 10 minutes and cost between $5,000 and $10,000. For systemic diseases such as lupus, some clinics also administer the cells intravenously, which can cost more than $10,000 per session.
Because amniotic stem cell treatments don’t undergo the clinical trials required for FDA approval, there’s little data or research on them. Their efficacy is highly questionable and, in one case where bacteria contaminated the supply, the lack of accountability in the industry has led to serious infections for a dozen patients. An investigation by ProPublica and The New Yorker found disgraced doctors who were recast as salespeople, manufacturers that cloaked themselves in pseudoscience and had few scientists on staff, and clinics that offer to treat conditions like multiple sclerosis or kidney disease without specialized training. Unscientific methods, deceptive marketing, price gouging and disregard for patients’ well-being were rampant across the amniotic stem cell therapy industry.
The supply chain for amniotic therapy starts and finishes with people who are at vulnerable times in their lives: the cells come from new mothers and go to chronically ill patients. Women who undergo cesarean sections are often asked to donate their birth tissue shortly before the procedure. By law, they can’t be compensated for it. Mothers who donated their tissue told ProPublica and The New Yorker that they assumed, or were assured, that it would be used for a worthy cause — and that otherwise it would be disposed of as medical waste. But they couldn’t recall the details of the donation process, owing to the haze of childbirth.
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The second-most-prolific political donors among the top-paid chieftains were Robert J. Hugin, the recently retired chief executive of the drug company Celgene, and his wife, Kathleen. Mr. Hugin gave $250,000 to a “super PAC” supporting New Jersey governor Chris Christie’s unsuccessful bid for the Republican presidential nomination and nearly $200,000 to national Republican committees.
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http://www.globalpossibilities.org/nature-and-technology-are-merging-what-does-that-mean-for-sustainability/
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http://www.alternet.org/environment/senates-first-biotech-hearing-decade-was-lopsided-pro-industry-affair
...
Central to the hearing is the the issue of labeling food products containing GE crops. Senator Stabenow called for the adoption of legislation on GE food labeling, presumably with language that will preempt the authority of states to adopt more stringent labeling standards. Senator Stabenow said that she wants labeling that “doesn’t stigmatize biotechnology.” The GE food industry is urging Congress to act to override state labeling before the Vermont label lawgoes into effect in July 2016.
RELATED: How Monsanto Solicited Academics to Bolster Their Pro-GMO Propaganda — Using Taxpayer Dollars
The committee heard government and industry witnesses on the federal regulation of agriculture biotechnology, with limited input from consumer critics. Two panels (one representing agencies, the other industry) received questions from the 20 committee members on GE crops, biotechnology, ad labeling. The agency panel represented “business as usual,” discussing administrative procedures at length, while the industry panel stressed the science of GE. The Just Label It group, a coalition of organizations advancing labeling, called for the public’s right to know. Environmental groups not invited to testify criticized the lopsided hearing and the government’s opposition to GE labeling of food.
While Senators spent two of the three hours questioning agency officials on their regulatory procedures of GE crops and biotechnology, no answers were given that address scientific studies needed to ensure their safety. When asked by Senator John Hoeven (R-ND) if there was anything that made GE crops harmful to the environment, all of the members of the regulatory panel said “no,” despite impacts of GE crop production on the environment, reliance on hazardous weed killers in herbicide-tolerant crops, and the associated decline of monarch butterflies.
EPA’s Office of Pesticide Program indicated that it registers “plant incorporated protectants” (PIPs) in 86 GE crops and acknowledged pest resistance problems. Insects that are the target of the engineered plant, incorporated with a pesticide, develop resistance, putting farmers’ crops at risk because of their dependency on the technology. Organic agriculture identifies genetic engineering as an “excluded method” and prohibits its use in certified organic production.
As the GE technology advances, farmers are increasingly threatened with crop loss, as was the argument made by Texas cotton farmers last year when 3 million acres of GE cotton was threatened by weed resistance to Monsanto’s herbicide-tolerant Roundup. The state of Texas, on behalf of the farmers, requested that EPA allow the use of a triazine herbicide not registered for use on cotton under an emergency exemption (Section 18 of the Federal Insecticide, Fungicide and Rodenticide Act), but EPA denied the request because it said that exposure to triazines, linked to hermaphroditism in frogs, “already show[s] unacceptable risk levels.”
RELATED: Orwellian Nightmare: Congress May Block States from Requiring GMO Labeling
In 2012, Washington State University researcher Charles Benbrook, Ph.D. found that the use of herbicides in the production of three genetically engineered herbicide-tolerant crops (cotton, soybeans and corn) has increased, contrary to industry claims that biotechnology will reduce pesticide applications. According to a series of studies in the journal *Weed Science*, at least 21 different species of weeds Monsanto’s “Roundup-Ready” crops, which leads to an increased pesticide use to try to combat resistance, escalating the pesticide treadmill effect. The latest herbicide tolerant GE corn and soybean plants are engineered to be used with the herbicide 2,4-D, one-half of the mixture of Agent Orange and linked to non Hodgkins lymphoma. Experts expect increased public exposure to 2,4-D through the food supply and in the environment, leading to weed resistance.
At the Agriculture Committee hearing, the first panel included of officials from the Environmental Protection Agency (EPA), Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA), and Food and Drug Administration (FDA). The Center for Food Safety and FDA’s Director of Applied Nutrition, Susan Mayne, Ph.D., took opposing positions on GE labeling with the government witness arguing that mandatory labeling is unnecessary because the Federal Food, Drug, and Cosmetic Act (FFDCA) does not recognize a “material” difference between GE and conventional crops. Senator Patrick Leahy (D-VT), a long-time member of the committee, cited the U.S. Patent and Trademark Office’s interpretation of GE crops as “novel for patent purposes” and asked the panel why agencies were in disagreement about the differences between GE and conventional crops. Dr. Mayne responded that, if there were a material difference in the food safety and nutrition between GE and conventional crops, FDA would support labeling.
The second panel consisted of five members of the agricultural, production, and consumer industry. Joanna Lidback, producer and farmer from the Farm at Wheeler Mountain, voiced her concerns about the costs associated with GE crops used to feed her dairy cows. She calculated an increase of $48,000 per year on her farm if GE feed was ever banned, but no calculations for the costs of the proposed GE label. With economic hardships in mind, organic farmers are threatened with adverse economic impact due to the contamination from GE pollen drifting onto their crops. Organic farmers also report losses due to a need to establish buffer zones.
In opposing labeling Daryl Thomas, Senior Vice President of Herr Foods, Inc., stated, “Mandatory labels on food products are reserved for critical information about nutrition and safety. GMO ingredients don’t change the nutritional profile or safety of our products.”
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srcwtch
The Biotechnology Industry Organization, known as BIO, was created in 1993 by the merger of two small Washington-based biotechnology trade organizations:
The Industrial Biotechnology Association (IBA), primarily represented larger, established companies on Capitol Hill and before federal regulatory agencies; the other, the Association of Biotechnology Companies (ABC), represented emerging companies and universities, and focused on technology transfer issues, meetings and other business development activities. [5]
According to The Hill, in November 2004, "The C2 Group ... signed the Biotechnology Industry Organization to gain congressional support for such industrial biotechnology issues as turning corn residues into usable plastics and establishing biorefineries." [6]
Contents
- 1 Lobbying
- 2 Public relations
- 3 FDA funding fees
- 4 Personnel
- 5 Contact information
- 6 Articles and resources
Lobbying
The Biotechnology Industry Organization does in-house lobbying, and contracts some business out to smaller lobbying firms, including the Alpine Group, Arent Fox LLP, and Akin, Gump, Strauss, Hauer & Feld.
2012 Lobbying Data
| Lobbying Firm | Amount Reported | Issue |
|---|---|---|
| Akin, Gump, Strauss, Hauer & Feld | $30,000 | Patent provisions in the Trans-Pacific Partnership trade negotiations; Patent provisions in the Trans-Pacific Partnership trade negotiations; |
| Alpine Group | $60,000 | S. 559, Securing America's Future with Energy and Sustainable Technologies Act Biofuels S. 1564, Renewable Fuel Parity Act of 2011 H.R. 3098, Renewable Fuel Standard Elimination Act; bio-based tax credit H.R. 3630, Temporary Payroll Tax Cut Continuation Act of 2011; FY 2013 Appropriations Legislation; Green chemistry S 847, Safe Chemicals Act of 2011; National Defense Authorization Act for Fiscal Year 2013; S. 2155, A bill to amend the Farm Security and Rural Investment Act of 2002 to promote biobased manufacturing.; |
| Arent Fox | $60,000 | Improving the regulatory process for products of crop biotechnology; Improving the regulatory process at the Department of Agriculture |
| Bates Capitol Group | $40,000 | Support legislation to increase access to capital information. Monitor Budget Process and Senate Votes (S.Con.Res.37, S.Con.Res.41, S.Con.Res.42, S.Con.Res.44, H.Con.Res.112).. Support repeal of IPAB. Support the TREAT Act to accelerate development of therapies for serious and life-threatening diseases, S.2113. Monitor S.3187, the Food and Drug Administration Safety and Innovation Act. |
| Biotechnology Industry Organization | $3,890,000 | TransPacific Partnership Sanitary and Phytosanitary Issues, Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning, Genetically Engineered (GE) Animals Labeling FDA Approval Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon, Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement, Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013, Regulatory Actions on Biological Pesticides, Climate Change Benefits of Biofuels, Department of Defense Applications of Advanced Biofuels (Opposition to Section 526 Repeal, Implementation of H.R. 1249: The America Invents Act of 2011, Discussions with EU on Animal Cloning, Funding for Biorefineries Energy and Water Development Appropriations Act for FY 2013, Biosimilars User Fee Act of 2012 (Discussion Draft) Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act, Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013, S 1855: Pandemic and All Hazards Preparedness Act Reauthorization of 2011, Reimbursement for Innovative Products: Medicare Part B Physician-Administered Products, Biodefense Research, Development and Procurement S 1855: Pandemic and All Hazards Preparedness Act Reauthorization of 2011, H.R. 3606: Jumpstart Our Business Start-ups (JOBS) Act, Tax for Seasonal Influenza Funding, |
| Nobel Strategies | $60,000 | Biotech Regulations Roundup Ready Alfalfa Roundup Ready Sugarbeets |
| The Russell Group | $160,000 | Biotech Acceptance; Agriculture, Competition, and Related Issues; Advocacy for Plant Protection Act concerns; FY 2013 Agriculture Appropriations Act; Work relating to seed trade issues with South America. |
| The Washington Tax Group | $90,000 | Issues related to extension and expansion of alternative simplified research and development tax credit (H.R. 942, S. 1577); issues relating to international corporate tax reform (S. 727, S. 2091). |
In 2008, The BIO spent $7.7 million on lobbying [1] They spent $7.3 million in 2009, [2] $8.4 million in 2010 [3], and 7.9 million in 2011 [4]
Public relations
Fake news
A promotional website for BIO's June 2008 convention states: [7]
BIO has retained DWJ Television to provide videography, TV, and radio broadcast services, as well as webcasting and podcasting, during the 2008 BIO International Convention. ...DWJ Television can shoot footage and edit a video for your exhibit booth or B-roll/soundbites for news broadcasters. ...DWJ will produce and distribute radio newsfeeds daily throughout the convention. DWJ will also maintain live fiber and satellite capability 24/7 for the delivery of important corporate news and interviews during the convention – to any and all TV stations in the U.S. or abroad.
BIO 2009
BIO hired the PR firm Environics Communications "to conduct public relations and media outreach for the association's 2009 BIO International Convention in Atlanta," Georgia, according to the Holmes Report. BIO vice president of communications Jeff Joseph remarked, "Environics Communications was selected because of the agency's strong health sciences knowledge and background, its relentless persistence in generating top-tier visibility for clients in traditional and new media, and its vast experience and understanding of how large trade associations operate." [5]
FDA funding fees
U.S. government regulating agencies don't negotiate their budgets with industries they oversee, with the exception of the Food and Drug Administration (FDA). In the early 1990s, the pharmaceutical industry began paying the FDA millions of dollars in user fees in order to speed up the drug approval process. These fees "now fund more than half the agency's critical drug-review process." Industry groups and the FDA renegotiate the fees and how they're used every five years, giving drug makers "considerable input into which programs receive funding." In 2006 the FDA negotiated an agreement with the Pharmaceutical Research and Manufacturers of America and Biotechnology Industry Organization. Industry groups pushed for even faster decisions on labeling and other "conditions" of new drugs and the FDA negotiated more funding to monitor drug safety following approval. [6]
Personnel
- James C. Greenwood - President and CEO
- Jeff Joseph - Vice president of communications
- Susan Desmond-Hellmann - Board member
Contact information
Biotechnology Industry Organization
1225 Eye Street NW
Suite 400
Washington, DC 20005
Phone: 202.962.9200
Email: info@bio.org
Website: http://www.bio.org/
Articles and resources
Related SourceWatch articles
- Biotechnology
- DWJ Television
- Henri A. Termeer - director
References
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important;-webkit-user-select:none"):}:↑ Opensecrets: Lobbying Report for the BIO: [1]. Accessed July 27th, 2012
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important;-webkit-user-select:none"):}:↑ Opensecrets: Lobbying Report for the BIO: [2]. Accessed July 27th, 2012
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important;-webkit-user-select:none"):}:↑ Opensecrets: Lobbying Report for the BIO: [3]. Accessed July 27th, 2012
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important;-webkit-user-select:none"):}:↑ Opensecrets: Lobbying Report for the BIO: [4]. Accessed July 27th, 2012
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important;-webkit-user-select:none"):}:↑ "Environics Manages PR for BIO International Conference," Holmes Report (sub req'd), February 15, 2009.
- :{Jump up:(style="top:-99999px;clip:rect(1px 1px 1px 1px);overflow:hidden;position:absolute !important;padding:0px !important;border:0px !important;height:1px !important;width:1px !important;-webkit-user-select:none"):}:↑ Anna Wilde Matthews Drug Firms Use Financial Clout To Push Industry Agenda at FDA, Wall Street Journal, September 2006
External resources
External articles
- Anna Wilde Mathews, "Drug Firms Use Financial Clout To Push Industry Agenda at FDA," Wall Street Journal (sub req'd), September 1, 2006.
Based in Washington DC, the Biotechnology Industry Organization (BIO) was established in July of 1993 under the leadership of Carl B. Feldbaum. By 2004 it had grown from 16 employees and a $2.1 million budget to almost a 100 member staff with a $40 million budget by 2004. Membership has increased from 350 to over1,000.
As the industry's major trade association, BIO represents large and small companies, as well as academic and research centers which use biotechnology to develop medical, agricultural, industrial and environmental products. BIO's members are not only in the U.S. but in 33 other countries. Its members include AstraZeneca, Aventis, Bayer, DuPont, Monsanto and Syngenta.
BIO says it aims to provide 'Biotechnology Information, Advocacy and Business Support'.It spent $14,166,000 on lobbying from 1998 to 2002. Biotech pharmaceutical companies and BIO have given more than $13 million in US election contributions since 1989.
BIO's 11th annual conference in June 2003 was addressed by President Bush, Homeland Security Secretary Tom Ridge and Food and Drug Administration Commissioner Mark McClellan. Carl Feldbaum was succeeded as BIO's President in 2004 by Congressman James Greenwood.
According to the Center for Responsive Politics, 'The association has four major lobbying priorities:blocking government price controls of biotech drugs; promoting genetically modified foods; streamlining the regulatory process for biotech products; and supporting tax incentives for the industry. Threats of bioterrorism have also propelled the industry - and its trade association - onto the homeland security front.'
A major hurdle for BIO in its promotion of the industry is its financial record. TheWall Street Journal in may 2004 in a front page article, headed 'Biotech's dismal bottom line: More than $40 billion in losses', noted, 'Biotechnology may yet turn into an engine of economic growth and cure deadly diseases. But it's hard to argue that it's a good investment. Not only has the biotech industry yielded negative financial returns for decades, it generally digs its hole deeper every year.' The WSJ pointed out that this truth becomes lost in periodic bursts of enthusiasm for biotech stocks.
David Ewing, writing in the San Francisco Chronicle commented on BIO's annual conference of June 2004, 'As of yet, most of what I'm looking for here is in the 'promise' category - and has been each year I have come to this ever-larger industry fete... Last year, this industry lost $5.4 billion, and has lost a staggering $57.7 billion since BIO last held its annual conference in San Francisco in 1994, according to an Ernst and Young study. Only a few companies have been consistently profitable in the 30 years since biotech was born - a few, such as Amgen and Genentech, fantastically so. Remove them, and the losses and numbers are far worse for the rest of the industry.'
L. Val Giddings is BIO's Vice President, Food & Agriculture, with specific responsibility for GM crops.
BIO has been quick to condemn research that raise questions about the impact of GM crops. When the scientist Arpad Pusztai was effectively fired, his research halted and his research team broken up, after he had raised questions about the safety of GM foods, L Val Giddings, on behalf of the Biotechnology Industry Organization, applauded Pusztai's dismissal, adding 'This is a study that should never have seen the light of day.' ( No Small (Genetic) Potatoes, January 10, 2000)
In April 2002 an Associated Press article on 'corporate meddling in academia' pointed the finger at BIO for instigating a campaign of pressure on the journal Nature over a Mexican maize study it had published by UC Berkeley researchers Quist and Chapela, which pointed to the contamination of native Mexican maize varieties by GMOs. 'Nature's publication of the study in September,' according to the article, 'almost immediately galvanized the Biotechnology Industry Organization into action. Led by the lobbying group, sympathetic scientists inundated the journal with complaints that the study's science was sloppy. They also denounced Chapela and Quist as politically biased.' (Corn study spurs debate over corporate meddling in academia, Associated Press).
When Nature distanced itself from the research it had published, BIO's Vice President, L. Val Giddings, told the Washington Post, 'We believe that Nature erred in publishing the article to begin with, and it seems they came to the same unavoidable conclusion. The authors . . . commitment was not to data and science but to a religious commitment to an [anti-biotechnology] dogma.'
Giddings' denunciation of the Berkeley scientists, as ideologically driven, was identical to the attacks which launched the campaign against them - attacks which surfaced first on the listserv of AgBioWorld, in messages from a 'Mary Murphy' and an **Go to a Printer Friendly Page**
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