- Swedish industry wants European medicines agency if UK quits EU (reuters.com)EFPIA Statement on Brexit (efpia.eu)
Sweden should become the new home of the European Medicines Agency if Britons vote to leave the European Union in a June referendum, according to the head of the Swedish pharmaceutical association...The agency, which approves medicines for all EU countries, has been based in London since it started in 1995. However, a so-called Brexit would leave Europe's equivalent of the U.S. Food and Drug Administration outside the bloc and could force a move...Shifting to Sweden would make sense, given the country's scientific strength and the leading role Swedish experts already play in European drug regulation…If the referendum in the UK results in a 'no' to the EU, the government should immediately launch an intensive lobbying campaign to make Sweden the new host country for the EMA...Many pharmaceutical executives also see a move as inevitable and they fear that a British "Out" vote would disrupt healthcare regulation in the world's biggest trading bloc...
- FDA should warn of risks of opioid, benzo combo, say public health experts (statnews.com)CITIZEN PETITION (health.baltimorecity.gov)Benzodiazepine prescribing patterns and deaths from drug overdose among US veterans receiving opioid analgesics: case-cohort study (bmj.com)
Public health officials around the country want the Food and Drug Administration to warn people about the risks of taking opioids along with common anti-anxiety drugs...Forty-one public health officials and researchers signed a petition, which will be submitted to the FDA... It calls for so-called black box warnings on both opioids and benzodiazepines, indicating that their concurrent use "contributes to the risk of fatal overdose." Opioids are intended primarily for pain relief; benzodiazepines, like Valium and Xanax, are tranquilizers that can treat anxiety...A 2015 study in the British Medical Journal found that US veterans taking opioids who took more benzodiazepines were more likely to die than those who took fewer benzodiazepines...Deaths from both opioids and benzodiazepines have been on the rise...
- Report calls out weak FDA stance on medical device cybersecurity, favors stronger regulation (healthcareitnews.com)Assessing the FDA's Cybersecurity Guidelines for Medical Device Manufacturers: Why Subtle 'Suggestions' May Not Be Enough (icitech.org)
...the Institute for Critical Infrastructure Technology, a bipartisan collaborative meant to bridge the gap between federal agencies and private-sector leaders in the interest of protecting the nation's technology backbone, claims recent guidance from Food and Drug Administration for device makers falls way short...In practically all matters of cybersecurity within the health sector, the FDA seems to be in a constant state of offering subtle suggestions where regulatory enforcement is needed..."Assessing the FDA's Cybersecurity Guidelines for Medical Device Manufacturers: Why Subtle 'Suggestions' May Not Be Enough," knocks the agency for failing to implement enforceable regulations for manufacturers...It may be beneficial to healthcare providers, healthcare payers, and legislators to petition the FDA to make the guidelines regulatory. Otherwise, medical device manufacturers could ignore the guidelines altogether...
- Q&A with US Representative Buddy Carter, the Only Pharmacist in Congress (pharmacytimes.com)
As the only pharmacist serving in Congress, US Representative Earl L. "Buddy" Carter is a critical leader of efforts to pass federal legislation pertinent to pharmacists...Pharmacy Times recently spoke with the first-term US Congressman, House Community Pharmacy Caucus co-chair, and Carter’s Pharmacy, Inc, owner about his pharmacy past and political progress.
- Why did you become a pharmacist?
- What part of the pharmacy profession stands out to you?
- How did you get into politics?
- Have you maintained your pharmacist license while serving in Congress?
- What is it like to be a pharmacist in Congress?
- How has being a pharmacist helped you understand and tackle legislative issues?
- What pharmacy-related objectives are on your to-do list in Congress?
- What are your thoughts about pharmacist provider status legislation and how are you advancing HR 592?
- What are your thoughts about PBM transparency legislation and how are you advancing HR 244?
- What are your thoughts about "any willing pharmacy" legislation and how are you advancing HR 793?
- What more do you plan to do to advance these 3 bills?
- What efforts is the House Community Pharmacy Caucus making to help community pharmacists?
- Senate confirms Dr. Robert Califf to lead FDA (reuters.com) New FDA head Robert Califf vows to use ‘bully pulpit,’ better explain agency decisions (washingtonpost.com)
The Senate voted overwhelmingly...to confirm Dr. Robert Califf as head of the Food and Drug Administration, an agency that regulates everything from food and drugs to tobacco, cosmetics and dietary supplements...Califf...a well-regarded cardiologist and researcher, takes the helm at the FDA when lawmakers are pressuring it to speed the approval process for drugs and medical devices and to finalize a proposed rule giving it authority to regulate e-cigarettes...He said one of his first priorities is to strengthen the workforce by reaching out to academic and other centers to attract new talent...Another priority...is improving surveillance systems to monitor for safety...We're not proposing to do away with the adverse event reporting system that currently exists...but we are acutely aware that it is not enough...Tools to monitor the safety of medical devices also need to be modernized...and though it will not happen overnight...we have to do the hard work of making it happen...
- Senate vote on Robert Califf may put him back on track for top FDA job (statnews.com)FDA to overhaul opioid policies. Will it ease concerns over Califf? (statnews.com)UPDATE: FDA chief nominee Califf likely to be confirmed after clearing key Senate vote (biopharmadive.com)How the opioid crisis convinced these senators to oppose advancing Califf nom, in charts (biopharmadive.com)
...Dr. Robert Califf...Obama’s choice to head the Food and Drug Administration, may be getting back on track to win final approval from the Senate...In a move designed to circumvent opposition to Califf, who was nominated in September, Senate Majority Leader Mitch McConnell has scheduled a procedural vote for Monday afternoon. If Califf wins the support of at least 60 senators in that vote, he would move on to a final confirmation vote — likely Tuesday — and his Senate opponents would lose their leverage to stop him...The move will likely vanquish the remaining senators — led by Democrats Bernie Sanders of Vermont, Edward Markey of Massachusetts, and Joe Manchin of West Virginia — who disapprove of Califf because of his close ties to industry and what they consider a poor FDA response to the opioid epidemic...
- Zika update: Vaccine race swells, PaxVax CEO on how to stop ‘chasing epidemics’
As the Zika virus continues to spread, more biotechs are announcing their Zika vaccine programs. Meriden,.. Protein Sciences,..GeoVax Labs and.. PaxVax are the latest...Getting caught off-guard by epidemics like this has happened time and time again. And "chasing" outbreaks instead of anticipating them rarely results in a vaccine being developed in time. Witness the most recent Ebola epidemic: Merck's experimental vaccine, the furthest along in a crowded field, won't be submitted for regulatory approval until 2017, more than two years after the outbreak started...we had known about Ebola for decades...Companies got a head start in 2014 from partly developed candidates that had been shelved away. It is not so with Zika. "Almost everyone is pretty much starting from scratch...To avoid this and have programs in place before an outbreak hits...governments and nongovernmental organizations...should create economic incentives for companies to make vaccines for neglected diseases like Zika...the FDA's priority review voucher system, in which a company developing a vaccine for a neglected tropical disease receives a transferable voucher for expedited FDA review. Malaria and dengue have been on the list of neglected diseases for years, but Zika is not yet on the list
- Most drug makers report incomplete side effects to the FDA (statnews.com)
The regulatory system for reporting side effects caused by prescription drugs is producing its own kind of side effect — incomplete information about injuries that patients may have suffered. And the reason for the lack of data is that many drug makers are filing patchy reports...At issue is the Adverse Event Reporting System...The database is the key method for collecting side effect data. Both doctors and consumers can voluntarily report problems to the agency or a drug maker. But drug companies are also required to investigate and report side effects that may be attributable to their products...drug makers generally fail to include key data that the FDA might use to assess future warnings. For this reason...there are still wider implications...With increasing pressure for the FDA to approve drugs fast but with less clinical testing, it is a major concern that postmarket surveillance has major problems that are not being addressed…It is time for the FDA, the medical community, and industry to start work on a badly needed modernization" of this "critical tool" for monitoring safety…reports involving patient deaths offered the least amount of complete information for all of the key data points...the reporting system has not kept pace with changes in pharmaceutical marketing...interactions between patients and physicians, and patients and drug companies, have evolved, partly thanks to the Internet. This means a report may not be based on spontaneous information.
- Engineers 3D Print Tissue That Mimics How The Human Liver Functions (forbes.com)
Engineers at the University of California...say they have successfully 3D printed life-like liver tissue that simulates how the human liver functions and is structured. The researchers say the tissue could be used as a platform for drug screening...In the case of Federal Drug Administration approval for a drug, on average it takes around 11 to 14 years and $2.6 billion to get a drug to market...Around 90% of drugs don’t pass animal tests or human clinical trials. In the case of the new 3D printed tissue, the researchers say pharmaceutical companies could use the tissue as platform in the lab to focus on drugs that appear to be more promising and eliminate drugs that have less efficacy...To create the liver tissue that mimics real human liver tissue, the engineers created a diverse combination of liver cells and supporting cells systematically organized in a hexagonal pattern under a microscope. But to print that complex tissue, they needed a 3D printer that could accommodate the 3D micro-structures found in biological tissue. The team created their own bioprinting tech in the lab capable of reproducing the elements and features of the tissue…I think that this will serve as a great drug screening tool for pharmaceutical companies and that our 3D bioprinting technology opens the door for patient-specific organ printing in the future. The liver tissue constructed by this novel 3D printing technology will also be extremely useful in reproducing in vitro disease models such as hepatitis, cirrhosis and cancer...
- Compounding pharmacies investigated for possible fraud tied to pain creams (healthcarefinancenews.com)
The Department of Justice is investigating potential fraudulent claims and billing linked to specialty creams...that claimed to treat pain symptoms...investigators have claimed many of these specialty creams have little or no medicinal value...the issue is with the alleged false claims, not the compounds themselves...It's part of a larger issue of healthcare fraud...All these people submitting claims … for drugs that have absolutely no effectiveness. Are they doing it with knowledge, and seeking reimbursement for it? It's the modern day snake oil salesman...the International Academy of Compounding Pharmacies said the creams in question "benefit people and are non-addictive."...No charges have been filed...