- 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."
- Theranos isn’t the only diagnostics company exploiting regulatory loopholes (theverge.com)
Avoiding pre-market verification is downright easy…Theranos isn’t alone in avoiding regulation using an easily exploited loophole — in fact, it’s just one among many…Pathway Genomics, Admera Health, and Strand Life Sciences are diagnostics companies that offer cancer tests that impact people’s health care decisions. None of these companies have published data about their tests in peer-reviewed journals. Nor were any of these companies required to show regulators that their tests worked before they started marketing them to patients and physicians. That’s because each of these companies has been making use of what's known as the "laboratory developed test" loophole — which makes avoiding pre-market verification downright easy...Under the LDT loophole, any company that develops and conducts a diagnostic test in their own lab…can avoid submitting that test to the FDA before using it on patients. This get-out-of-regulation-free card exists because research hospitals often modify commercial tests. In the case of these hospitals, the academic researchers tend to publish their results anyway…The FDA knows this — even they’ve been calling LDTs a loophole — and the agency wants to change the way these tests are regulated…until that loophole closes, we’ll keep seeing companies using the LDTs as a dodge, because it’s a simpler and cheaper way to get to market. The real expense, of course, is patients’ health.
- FDA Offers a Multitude of Options for Pharmacy Students (pharmacytimes.com)
The FDA is an exciting and respected career option for students unsure about what to do when they graduate from pharmacy school…advice to pharmacy students interested in a career with the FDA is to apply for the Pharmacy Student Experiential Program during their third professional year so that they can gain exposure to the agency and network…final-year students, (Lindsay E. Wagner, PharmD) suggested attending continuing education or poster presentations by FDA speakers at meetings and introducing themselves…those who are already in their residency or fellowship program can ask if their postgraduate program has any connection with the FDA or other public health agencies. There is always the possibility that a pharmacy student could do an optional rotation or shadow someone at the agency.
- 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.
- 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.”
- 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…
- 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...
- More than 100 women sue over mispackaged birth control after becoming pregnant (mcall.com)
More than 100 women who became pregnant after allegedly taking mispackaged birthcontrol pills filed suit in Philadelphia last week against Qualitest Inc., a subsidiary of the Irish drug-maker Endo Pharmaceuticals Inc…The case seeks millions in damages, including in some cases the costs of delivering, raising, and educating the children borne of the unplanned pregnancies…The discovery of the mispackaged contraceptives prompted the FDA in 2011 to issue a recall notice for 3.2 million blister packs, according to court filings…. The FDA recall was triggered when a Kansas City woman returned a package to her pharmacist after noticing the blister pack had been rotated 180 degrees, reversing the weekly tablet orientation, according to the suit filed in Philadelphia Court of Common Pleas.
- 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.
- Challenges of Pain: Part 2 – Pharmacies in the crosshairs: Prescription drug crime and law enforcement (pharmacist.com) Pharmacy Crime: A Look at Pharmacy Burglary and Robbery in the United States and the Strategies and Tactics Needed to Manage the Problem (apps.phmic.com)Challenges of Pain: Part 1: Impact of government responses on frontline pharmacists and patients (pharmacist.com)
…law enforcement side of prescription drug abuse—including the rise in pharmacy crime, such as robberies, and second in Pharmacy Today’s “Challenges of Pain” series. The series shows how pharmacists and their patients with legitimate pain needs are affected by issues and efforts around prescription drug abuse.
- Concern for pharmacists’ safety
- Preventing robberies: Start with the basics
- DEA adds to its focus
- GAO report: Questions raised about DEA’s approach
- GAO surveys of DEA registrants
- DEA: Patient access not affected
- Be aware and prepared