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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…

India's generic drugs could face new price controls as early as next year, as the prime minister's office pushes for an investigation of what one official in press reports called "astronomical" markups by drugmakers, suppliers and retailers…The office reportedly ordered the Department of Pharmaceuticals to look into the large markups that occur on generics that are sold through distributors…a panel already has been established to include the department, the National Pharmaceutical Pricing Authority and the Competition Commission of India, as well as industry groups…For several years, the government has attempted other ways to make generics more affordable to Indians, including the establishment of its own drug store chain, Jan Aushadhi. By the end of the year, the group expects to have more than 400 generics for sale, compared with the 225 now available. Within two years, the government expects to have 3,000 Jan Aushadhi stores throughout the country.

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."

Hussein “Sam” Arwada also admitted to defrauding the health care system of $2.3 million…physician who practiced in Warren, Michigan, was sentenced to 84 months in prison today for writing prescriptions for oxycodone and other controlled medications without medical justification, and for health care fraud…he conspired with James Lyons, a patient “marketer,” and others, to write prescriptions for 80,000 doses of oxycodone, and other controlled medications. The prescriptions were written in the names of people who were brought to him by Lyons and other marketers, for no legitimate medical purpose. The marketers then bought the pills from the “patients” and re-sold them to street dealers. Awada then used the patient data...to submit bills to Medicare and Blue Cross Blue Shield for services that were either never performed or were medically unjustified. Awada caused these same patients to receive monthly x-rays, and other invasive tests, which were medically unnecessary but helped to conceal his fraud.

Suggesting that India's chief drug regulator may not be doing enough to protect certain volunteers in clinical trials, the Supreme Court ordered the agency to provide adequate oversight, particularly when drugs to treat the human papillomavirus are concerned…Central to the high court's concerns, it said, were Merck Sharpe & Dohme's Gardasil and GlaxoSmithKline's Cervatrix...The two justices presiding said they were not trying to run the Drugs Controller General of India, but they believed the poverty-stricken and others in trials should be protected at the informed-consent stage when testing HPV vaccines… The court said the procedure should be transparent and patients should be compensated when failures occur.

Offenders facing court-ordered drug tests in Reno Municipal Court have often found ways around the system. That just got a lot harder and consequences for cheaters a lot swifter…Their crimes may vary…But the common underlying cause is substance abuse. That makes them potential candidates for one of the specialty courts. Instead of housing them behind bars, they are sentenced to sobriety and a rigorous schedule of random testing… But the court now has a new drug-screening lab. Samples, as many as 54 at a time, can be analyzed for 11 kinds of drug or alcohol content. Accurate results in minutes…The lab is the first of its kind in northern Nevada.

Drug Enforcement Administration…announced today the publication of a statewide Drug Overdose Assessment for Pennsylvania. The report, entitled “Analysis of Drug-Related Overdose Deaths in Pennsylvania, 2014,” is the first comprehensive assessment of deaths caused by drugs for the commonwealth…DEA received information from 62 of the state’s 67 counties on 2,497 deaths caused by the misuse of illicit drugs and diverted pharmaceuticals. Heroin was the most frequently identified drug (more than 51 percent of deaths), and more than 60 percent of the decedents showed the presence of an opioid. Also of note, 12 rural counties were among the 20 counties with the highest rate of drug-related deaths per 100,000 people.

French hospitals' mass casualty response can be a guide for United States..The horrifying attacks on restaurants, clubs and cafés in Paris last week have resulted in a call by U.S. federal agencies for healthcare providers and hospitals to review their disaster plans and to exercise "enhanced vigilance"…Department of Homeland Security and Health and Human Services urged healthcare providers this week to "review and exercise their security plans" in the wake of the attacks…The notice urged healthcare organizations to:

• Review security plans and conduct drills that incorporate scenarios based on tactics recently used
• Review active shooter, suspicious activity reporting, and counter-IED preparedness in training and awareness initiatives and in organizational safety briefings
• Ensure proper functioning of emergency communications equipment and conduct regular tests

Today FDA is issuing a report that illustrates the real and potential harms to patients and to public health from certain laboratory developed tests (LDT) – tests that are designed, manufactured and used in a single laboratory…But times have changed. LDTs have increased in complexity and availability and are now frequently used to diagnose common, serious medical conditions, including cancer and heart disease, with potentially greater impact on patients...LDTs are still under a general policy of enforcement discretion. That means they have rarely undergone FDA review to determine whether they are accurate, reliable, and provide clinically meaningful results...FDA’s own adverse event reporting databases rarely capture problems associated with a faulty LDT...the Agency was able to pull together 20 case studies based on information available in the public domain that show how lack of LDT oversight may be causing or is causing significant harm to patients…FDA has proposed to step up our oversight of LDTs. We issued a draft guidance last year which we’re currently working to finalize, that proposes to phase in enforcement of premarket review requirements for LDTs. FDA oversight would help ensure that tests are supported by rigorous evidence, that patients and health care providers can have confidence in the test results, and that LDTs have more scientifically accurate product labeling.

Yet another sign of trouble for Valeant Pharmaceuticals has emerged. The beleaguered drug maker already faces congressional hearings into its pricing practices. Now, one of its bread-and-butter product lines may not ring the register as often as before…Fewer dermatologists are prescribing Valeant medicines…The change constitutes more fallout from a scandal involving the drug maker’s relationship with a mail-order pharmacy known as Philidor Rx Services. Valeant reportedly hid its ties to the pharmacy in order to inappropriately boost prescriptions and insurance reimbursements...68 percent are writing fewer prescriptions for Valeant’s dermatology products and a similar percentage expect they will not prescribe Valeant drugs in coming months.