Protesters Deliver Outgoing FDA Commissioner an 800lb “Heroin Spoon”

Protestors descended on the FDA today to mark the end of Scott Gottlieb's tenure with the delivery of a large “heroin spoon” sculpture stamped with the FDA’s logo. Activists say they are angry that the outgoing commissioner rubber-stamped Dsuvia, an incredibly powerful opioid that is meant for surgeries and late-term terminal cancer. The group of activists urged the FDA to stop approving “dangerous” opioids and to focus on more ideas for medication-assisted treatment and other drugs to help treat addiction. Dsuvia is a sublingual formulation of sufentanil, which is 500 times as powerful as morphine. The drugmaker says that the drug was created for the management of acute pain in adults in medically supervised healthcare settings. Activists and addiction specialist believe that the drug will eventually make it onto the street, causing overdose deaths, just like fentanyl. Fentanyl was developed mostly for surgical settings but after a few years began to be prescribed off-label for chronic pain, causing addiction or dependence in its patients. AcelRx Pharmaceuticals, says that the…

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Smaller Pill Packs a Priority for FDA

President Donald Trump is planning on signing bipartisan bill H.R. 6 into law next week. When this happens, the new legislation will be going into effect the week of October 22, according to Scott Gottlieb, the FDA commissioner, who recently spoke at a Politico event. The first thing his agency wants to tackle? Creating smaller pill packaging for opioids, in hopes that it will prevent people from abusing their prescriptions for acute pain. The legislation affects Purdue Pharma, Johnson & Johnson, and other large opioid manufacturers. It will force them to create new packaging for the drug to accommodate small quantities. The provision is an effort to prevent excess pills from being prescribed. With this policy, doctors may prescribe more limited amounts of pills. This could also prevent people from keeping leftover opioids around. “The first thing that we’re going to do is the blister packs,” Gottlieb said. “Nobody should be getting 30 days for a wisdom tooth extraction,” Commissioner Scott Gottlieb said about the measure. He also said…

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Oxycontin Manufacturer Helped Write the Laws it Claims Justify Marketing

Mired in lawsuits, Oxycontin manufacturer Perdue Pharma is quick to deflect blame when it comes to the opioid crisis. Marketing tactics such as paying doctors to do little more than discuss the drug with their colleagues and pushing the drug to ER physicians were all legal, according to the company. But is this reality, or are these the pleadings of a company that is watching its ship sink? The truth is more complicated than that; it turns out. The FDA and Purdue Pharma have a close relationship, although until recently, the FDA may not have realized it. Purdue Pharma operatives were consulted when the FDA created policies that affect the entire nation, often getting the government agency to agree to policies and procedures that limit the manufacturer’s liability. However, the FDA officials didn’t realize that Perdue was paying the people they were consulting with to continue promoting Oxycontin. These operatives were the people consulted when the FDA refused to put limits on how doctors prescribe Oxycontin, meaning that doctors…

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Is Kratom an Opioid? The FDA Says Yes

The Food and Drug Administration put out new warnings about kratom, saying that the drug is best classified as a substance with “opioid properties” and linking it to 44 deaths. Previously, the DEA took steps to outlaw the drug altogether but halted their actions as Kratom advocates led campaigns against the agency involving petitions and phone calls. Kratom has become popular among people with opioid use disorder trying to get clean from heroin and other potent, addictive drugs. People with chronic pain, depression, and a myriad of other diseases. Often, sellers of Kratom market the drug in capsule, powder, and tea form. People claim it helps ease the symptoms of a wealth of diseases. While these benefits sound great, there are many people in the addiction community that believe that replacing opioids with Kratom is a dangerous and unsustainable practice. For years, people in Southeast Asia similarly used Kratom – as a substitute for opioid drugs and to ward off symptoms of opiate withdrawal. However, once a person has…

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Feds Crack Down on Illegal Online Pharmacies

Many prescription drug abusers have discovered how easy it is to use the Internet to obtain painkillers, stimulants and tranquilizers without a prescription. As part of an international crackdown on prescription drug abuse, the federal government has been taking action against online pharmacies that sell prescription drugs without requiring a prescription. In October, the U.S. Food and Drug Administration participated in a global effort to combat the online sale of illegal and counterfeit drugs. The effort, which was called Operation Pangea V, led to seizure of drugs valued at more $10 million and the shutdown of more than 18,000 illegal pharmacy websites.   Feds Target Google, FedEx and UPS   The U.S. Justice Department has targeted online pharmacies since 2005. The agency's focus has recently moved beyond individual website operators to the service providers that have enabled drug sales and deliveries. In 2011, Google agreed to pay $500 million to the Justice Department to settle charges that it displayed ads for Canadian companies that sold prescriptions illegally to U.S.…

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