Making cost-saving drugs more accessible
(WNS)–The U.S. Supreme Court just issued a ruling that will cut the time it takes for copycat versions of biologic drugs, drugs made from living cells, to hit the market. The decision is bad news for makers of brand name biologic drugs because it will shorten the length of time they can avoid competition and keep so-called biosimilars off the market. Health insurers estimate biosimilars, which are used to treat a range of conditions including Crohn’s disease, ulcerative colitis, rheumatoid arthritis, breast cancer, and diabetes, can save consumers billions of dollars annually. Prior to the court’s decision, manufacturers had to notify the brand name drug maker six months before marketing a biosimilar. At issue was whether the biosimilar manufacturer had to wait for Food and Drug Administration (FDA) approval, a process that can take months or longer, before it could give notice. A lower court ruled that notice could not be given prior to FDA approval, but the Supreme Court overturned that ruling.
Unprecedented Lawsuit Could End Water Fluoridation in US Based on Neurotoxicity Studies
The Fluoride Action Network (FAN), along with a coalition of environmental and public health groups has filed a complaint in the U.S. District Court for the Northern District of California against the U.S. Environmental Protection Agency (EPA) in response to their denial of our petition under Section 21 of the Toxic Substances Control Act (TSCA) seeking a ban on water fluoridation. We believe this lawsuit is an unprecedented opportunity to end the practice once and for all in the U.S., and potentially throughout the world, based on the well-documented neurotoxicity of fluoride. According to FAN’s attorney and adviser, Michael Connett: “This case will present the first time a court will consider the neurotoxicity of fluoride and the question of whether fluoridation presents an unreasonable risk under the Toxic Substances Control Act (TSCA). And, in contrast to most other legal challenges of Agency actions, TSCA gives us the right to get the federal court to consider our evidence ‘de novo’ — meaning federal courts are to conduct their own independent review of the evidence without deference to the EPA’s judgment.”
What’s the Difference Between Companies Selling Cigarettes and Companies Selling Vaccines?
Do you know the difference between companies that sell cigarettes and companies that sell vaccines in America? When cigarettes injure or kill people, tobacco companies are financially liable in civil court. But when vaccines injure or kill people, drug companies are not. That’s right. If you get lung cancer from smoking cigarettes, you can sue the tobacco company. But if you or your child suffers brain damage or dies after getting a vaccine, the drug company cannot be sued. And you can’t hold any person who licensed, recommended, gave or voted to mandate the vaccine accountable in a court of law, either. Here is why: In 1986, Congress gave drug companies a partial civil liability shield for vaccine injuries and deaths. In 2011, the US Supreme Court effectively banned all vaccine injury lawsuits, ruling that vaccines are – quote – “unavoidably unsafe.” Then, in 2016, Congress lowered licensing standards for experimental vaccines so that drug companies can fast track them to market without conducting large clinical trials. Now, drug companies and their friends in medical trade are lobbying state legislatures to strip vaccine exemptions from state public health laws. That’s right. Even though drug companies and doctors have been given an unprecedented liability shield removing all responsibility for vaccine injuries and deaths, they want more. They want “no exceptions” vaccine laws forcing you and your children to use every dose of every government endorsed vaccine without your voluntary, informed consent.