The FDA said it is evaluating the risk of cardiovascular events associated with the use of approved testosterone products following the publication of two research studies that showed an increased risk for some men.
Testosterone is approved for hormone regulation, certain genetic conditions and problems associated with chemotherapy treatment. A national campaign at alerting men to the presence of "low-T" has driven higher sales for testosterone in recent years.
Bayer will enter the traditional Chinese medicine market through the full acquisition of Dihon Pharmaceutical Group, a China-based manufacturer of over-the-counter (OTC) and herbal traditional Chinese medicine products, according to a company announcement.
Dihon's TCM products include Dan E Fu Kang for treating women's health conditions, and OTC products include Kang Wang, a dandruff treatment, and Pi Kang Wang, an antifungal cream.
Bayer HealthCare CEO Olivier Brandicourt said the acquisition will strengthen Bayer's business in China.
The companies did not disclose the selling price.
About 1-in-10 cancer clinical trials are discontinued early because they failed to recruit enough patient participants, according to an analysis of 7,776 trials listed on Clinicaltrials.gov between September 2005 and November 2011. All of the trials were phase 2 or phase 3 studies of cancer treatments for adults.
Matthew Galsky of the Icahn School of Medicine at Mount Sinai Hospital in New York said about 20% of the studies weren't completed because of failure to recruit the needed number of volunteers to make the test viable. He said company-sponsored studies were discontinued for lack of enrollment more often than government or foundation supported research.
Galsky shared his findings earlier this year at an American Society of Clinical Oncology briefing.
Two Congressional oversight committees concluded February 26 that the FDA overstepped its authority and trod on whistleblower protection laws when it monitored staff communications with members of Congress. In 2007, the FDA used a software program called Spector 360 the track the online activity of five employees that had contacted members of Congress over their concerns about the agency's medical device approval process.
Sen. Charles Grassley of Iowa stated at the hearing that FDA scientists who contacted the Office of Special Counsel, the president's transition team and members of Congress to express their concerns were protected by whistleblower laws. "The FDA was intently spying on the whistleblowers," Grassley said. "There was no effort to avoid snooping on legally protected communications. This surveillance was much more intense than the routine monitoring of government employees on government computers."
Walter Harris, the FDA's chief operating officer and acting chief information officer, spoke in defense of the FDA's staff surveillance policies. "FDA employees are subject to monitoring of their use of government-owned equipment in accordance with policies developed to comply with FISMA [Federal Information Security Management Act]," Harris told the joint House Oversight and Government Reform and Senate Judiciary panel. Harris asserted that the monitoring is necessary to maintain cyber security and protect public data. "As required under FISMA, FDA employs IT security controls throughout the Agency's IT Enterprise. These IT controls are employed to ensure the confidentiality, integrity, and availability of FDA data and are consistent with the management, operational, and technical controls outlined in NIST Special Publication 800-53." Harris said additional laws "expressly prohibit FDA personnel from disclosing trade secrets and confidential commercial information unless authorized by law."
For more information:
Witness and testimony documents: Limitless Surveillance at the FDA: Protecting the Rights of Federal Whistleblowers
Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals Inc., have asked the Arkansas Supreme Court to reverse a $1.2 judgement decided by a Pulaski County jury in 2012. The companies were penalized for off-label marketing of Risperdal, an anti-psychotic drug.
The companies' lawyer argued February 27 that the State of Arkansas improperly applied federal regulations against Medicaid fraud in the suit, when there was no proof of improper reimbursements. However, the state attorney general said improper marketing and failure to communicate the risks associated with Risperdal, of which the companies were found guilty of, equated to fraud.
Sixty-five Arkansas legislators filed an amicus curiae, or friend of the court, brief stating the law was applied properly. Attorney generals representing 35 other states also filed a brief asking the Arkansas Court to uphold the lower court's judgement.
In a separate case, the U.S. Justice Department won a $2.2 billion settlement against Johnson & Johnson in November 2013 for criminal and civil allegations that the company marketed Risperdal and other psychiatric drugs for off-label use in children, seniors and disabled patients.
A new study published in JAMA's Pediatrics is sure to add to the debate about possible pharmacological causes of the global increase of attention deficit and hyperactivity disorder (ADHD) in children.
In an analysis of survey data on more than 64,000 Danish women who took acetaminophen, also called paracetamol, during pregnancy, researchers found that 37% higher chance of having a child who would be diagnosed with hyperkinetic disorder, a severe form of ADHD; a 29% higher risk of having a child that would be prescribed drugs for treating ADHD; and a 13% higher risk of exhibiting ADHD-like behaviors by age seven.
Previous studies suggest that acetaminophen use during pregnancy can affect the developing fetal brain due to interference with normal hormone function.
The study covered data obtained between 1996 and 2002 and is published in the February 24 Pediatrics.
In the United States, ADHD diagnosis rose 42 percent, to reach 6.4 million children in 2012, according to a study by the Centers for Disease Control and Prevention (CDC).
The FDA rejected a new drug application from RedHill Biopharma Ltd, Israel, and IntelGenx Corp. of Canada, after raising questions about the product's third-party manufacturing process, as well as the packaging and labeling of the drug, called RHB-103, according to a statement released by the companies.
The companies said they are working with the FDA to address the concerns. 'While continuing to review the FDA's CRL, RedHill and IntelGenx believe that they can supply the requested information based on available data. IntelGenx and RedHill further believe that the majority of issues raised by the FDA were recently addressed in an amendment submitted by the companies to the FDA that has yet to be reviewed. The companies will work with the FDA to address the remaining questions in the CRL and plan to submit the requested information within a few weeks," according to the statement.
Pfizer's Duavee, a new estrogen-based drug for managing hot flashes caused by menopause, is due to hit at least some pharmacy shelves February 3.
According to Pfizer's website, about half of all post-menopausal women experience hot flashes. That's a potential market of 15 million. However, time will tell if women are willing to start or return to estrogen-based therapies for relief.
The FDA approved Duavee for moderate-to-severe vasomotor symptoms on October 23, 2013.
One of the new hepatitis C drugs approved by the FDA late last year has set off a payer's and consumer's revolt due to its price.
While pubic health experts, physicians and patients have longed for better treatments for the disease which has approached epidemic proportions in recent years, consumers are finding the $1,000 a day pill a bitter one to swallow. About two dozen protesters turned up outside Gilead's meeting with potential investors last week in San Francisco, according to Bloomberg.
Efforts to curb the spread of antibiotic resistant infection among humans has made some headway over the past couple of years due to significant national research, resolve and resources. However, the continuing practice of delivering risky antibiotics in animal feed reported this week feels like one step forward, two steps back.
More than half of 30 penicillin and tetracycline antibiotic feed additives on the market today pose a "high risk" of exposing humans to antibiotic-resistant bacteria through the food supply, according to a decade-long study by the FDA that ended in 2010. Yet these additives, which don't meet the FDA's current safety standards, remain on the market because regulators haven't made the call to remove them.
In this case, non-therapeutic use refers to antibiotics used for growth promotion or disease prevention in livestock and poultry.
The revelations came about following Freedom of Information requests (FOI) filed by a non-profit advocacy group. In its detailed 971 page report, the Natural Resources Defense Council (NRDC) outlines years of discussion over the issue, dating back to the 1970s, and even earlier.
While two of the antibiotic feed additives were voluntarily withdrawn by the manufacturers, the NRDC alleges that the FDA has made no effort to pull the remainder off the market.
"The use of tetracyclines and penicillins in animal feed is part of a larger problem of antibiotic overuse," says the NRDC. "Approximately 70 percent of all sales of medically important antibiotics in the United States are for livestock use. Scientists have demonstrated that nontherapeutic use of antibiotics to raise livestock promotes drug-resistant bacteria that can migrate from livestock facilities and threaten public health. These bacteria can spread resistant traits to other bacteria, and some of these shared traits also can confer resistance to antibiotics used primarily in human medicine."
To be fair, the FDA runs a gauntlet between antibiotics manufacturers, public health advocates, industry trade groups, and the U.S. Congress; the latter two of which have different missions yet their members often form questionable alliances.
NRDC wants the FDA to find its backbone and take stronger action, specifically withdrawing approval of penicillin and tetracyclines in animal feed and limiting their use to treating sick animals and, in rare cases, controlling disease outbreaks. It seems the FDA has made several failed -- some may say half-hearted -- attempts to do just that. In her run-down of the long-running debate over non-thereaputic use of animal antibiotics last year, Wired journalist Maryn McKenna offered a timeline that begins in 1951, with the approval of penicillin, chlortetracycline and oxytetracycline as feed additives.