- FDA approves Adapt Pharma’s nasal spray for opioid overdose treatment (reuters.com)
Food and Drug Administration approved the first-ever nasal spray emergency treatment for opioid overdose…The spray, developed by privately held Adapt Pharma Ltd, uses naloxone, a drug used to treat opioid overdose for nearly 45 years but approved only in injectable forms…The treatment…is expected to have wide coverage under health insurance with affordable co-pays…Group purchasers, such as law enforcement, fire fighters, departments of health, local school districts, colleges and universities, and community-based organizations will be able to purchase the spray at a discounted price of $37.50 per 4 mg device…
- FDA Amends Liver Warning Labeling Guidance for Some OTC Drugs Containing Acetaminophen (raps.org)Acetaminophen Guidance for Industry (fda.gov)
Food and Drug Administration…unveiled amended guidance on the liver warnings that must be contained in labels of some over-the-counter drugs containing acetaminophen, saying it will allow manufacturers in some cases to warn patients against taking more than 4,000 mg of acetaminophen in 24 hours… helps to clarify certain cases where manufacturers of internal analgesic, antipyretic and antirheumatic OTC drugs would be able to change liver warnings when the product’s directions for use result in a maximum daily dose of acetaminophen that is less than 4,000 mg for adults… FDA says that the optional statement, “for this product,” from the original warning is intended to help consumers understand that the maximum number of daily dosage units for a product might not reflect the maximum daily dose of acetaminophen… in certain circumstances, despite this optional statement, the wording might be interpreted as indicating that severe liver damage is associated with a total daily dose of acetaminophen that is less than 4,000 mg, which “is not the intent of the regulation.”
- CDC is right to limit opioids. Don’t let pharma manipulate the process (statnews.com)
…Americans overdose and die after taking opioid painkillers...people abuse or misuse the drugs…addictions and deaths mount…authorities are struggling to cope…State lawmakers are introducing bills to restrict prescribing…Food and Drug Administration is pushing pharmaceutical companies to develop more tamper-resistant products…the most sweeping initiative comes from the Centers for Disease Control and Prevention, which has prepared preliminary prescribing guidelines for primary care physicians…call on doctors to prescribe opioids only after other therapies have failed…there is considerable opposition to the guidelines…critics…say the CDC guideline process was flawed and, as a result, some patients will be denied much-needed pain relief.
- Many ‘me-too’ drugs didn’t start off that way: report (pharmalot.com)Nearly All Later Entrants to Drug Classes Were in Clinical Testing or Regulatory Review Before First-in-Class Approval (csdd.tufts.edu)
For many years, drug makers were criticized for racing to market with so-called me-too medicines. These are drugs that arrive in the marketplace after the first in a particular class of medicines is approved for treating a certain malady…Instead of developing something that offers little, if any, improvement over a first-in-class drug…critics have contended that drug makers should use precious R&D resources to focus on developing therapies for ailments that are lacking treatments…Now...a new analysis suggests the me-too phenomenon often occurred because companies were simply engaging in concurrent drug development, rather than opportunistic efforts to ride on the coattails of a successful medicine.
- Califf Breezes Through Nomination Hearing for FDA Chief (medscape.com)
Most members of a Senate committee had few reservations yesterday about Robert Califf's qualifications to be the next commissioner of the US Food and Most members of a Senate committee had few reservations yesterday about Robert Califf's qualifications to be the next commissioner of the Food and Drug Administration.. Questions about Dr Califf's ties to the pharmaceutical industry, however, have dogged him since President Obama nominated him…to lead the FDA…Trying to head off those concerns, Chairman Alexander noted at the outset of the hearing that Dr Califf had gone through an extensive vetting process that involved the White House, the FBI, the Office of Government Ethics, and dozens of pages of questions from the HELP committee…Sen. Elizabeth Warren confronted Dr Califf directly about his past relationships with drug companies. "It's no secret that during your time at Duke University you received significant financial support from the pharmaceutical industry both personally and through your research,"...She asked him whether he believed that the FDA should lower its standards for approval…"I've never been a proponent of lowering standards," said Dr Califf. "If anything, I've argued for raising standards."
- Drug makers beat diabetes lawsuits with an unusual ruling (pharmalot.com)
Several drug makers were handed an unexpected victory this week when a federal judge ruled they weren’t required to update product labels to warn about risks of pancreatic cancer with their diabetes medicines…District Court Judge…explained the labeling changes were not required because the Food and Drug Administration would not have approved those changes. As a result, approximately 750 cases are being tossed…“Right now, it’s a ruling by one district judge in California. So at this point, it doesn’t have huge implications. But there is, potentially, a lot at stake here for the plaintiffs and similar cases,” he tells us. “If the companies were to prevail, it could become an important precedent for companies in similar cases, because it could clarify what a manufacturer has to show to avoid liability.”
- FDA sends warning letter to DNA4Life over consumer gene tests (reuters.com)Direct-to-consumer company tests FDA's resolve on gene testing (reuters.com)
Food and Drug Administration sent a warning letter to…gene testing company DNA4Life over its sale of an unapproved direct-to-consumer gene test to predict drug response…the agency said it was unable to identify any FDA clearance for the company's test. The letter follows 23andMe's limited relaunch last month of a series of direct-to-consumer tests after the agency ordered the tests off the market...
- American Medical Association wants to ban drug ads to consumers (statnews.com)AMA Calls for Ban on Direct to Consumer Advertising of Prescription Drugs and Medical Devices (ama-assn.org)
American Medical Association is calling for a ban on advertising prescription drugs and medical devices directly to consumers. The move…is largely symbolic, because any ban would have to be authorized by Congress…The new AMA policy comes after years of complaints by physicians…some ads too often encourage patients to seek medicines unnecessarily. They also resent the pressure the ads place on them to write prescriptions out of concern patients will switch physicians…Another rationale for the ban, however, is the rising cost of drugs…many of the ads aimed directly at consumers promote more expensive medicines…the Pharmaceutical Research and Manufacturers of America…“Providing scientifically accurate information to patients so that they are better informed about their health care and treatment options is the goal of direct-to-consumer pharmaceutical advertising...“Beyond increasing patient awareness of disease and available treatments, DTC advertising has been found to…encourages patients to visit their doctors’ offices for important doctor-patient conversations about health that might otherwise not take place.”...
- Drug makers kept many clinical trial results a secret: study (pharmalot.com)
When it comes to disclosing clinical trial data, some drug makers are still keeping secrets, according to a new study…Thirty-five percent of all trial results for 15 drugs that were approved in 2012 by the Food and Drug Administration were not publicly disclosed. And nearly 30 percent of the trials conducted for those drugs failed to meet legal disclosure requirements…“This confirms that pharmaceutical companies often fall below legal and ethical standards,”…The findings come amid growing clamor from academics and consumer groups to press drug and device makers to release trial data. If research is not published or reported in accessible registries, physicians and patients are prevented from having a complete picture of the risks and benefits of medicines…Such concerns have been heightened following various safety scandals that revealed trial data for some products was never fully published or disclosed. A few notable examples include…Vioxx.. and…Paxil…Over the past year, regulators in the US and Europe responded to concerns by releasing new rules designed to widen access. The World Health Organization has released a new position statement calling for companies to publish all research studies…Sense About Science, a UK nonprofit that launched the AllTrials campaign to widen access to data, is working with 85 asset managers and pension funds to assess steps taken by drug makers to provide trial information…
- Direct-to-consumer company tests FDA’s resolve on gene testing (reuters.com)
Just as 23andMe has made peace with the...Food and Drug Administration, another direct-to-consumer genetics company is testing the regulatory waters with the launch of a $249 DNA test designed to predict drug response…The test, from tiny startup DNA4Life...comes in the wake of 23andMe's two-year tussle with the FDA over its direct-to-consumer personal DNA testing service, which the FDA ordered off the market in 2013…But the agency has yet to approve direct-to-consumer tests for pharmacogenetics, a field experts believe could be much riskier in the hands of consumers, who might use the information to make decisions about the drugs they are taking…"We would be delighted to have a conversation with the FDA," but added that it is not under the agency's purview. "Of course, the government can do what it likes."…The problem…is that patients, and even doctors, struggle to understand what to do with the results.