- Another Court Weighs In on Whether Off-Label Promotion is Per Se Illegal; Jury Finds Both Defendants Not Guilty on All Counts (fdalawblog.net)
On February 25...upon conclusion of the...criminal case...United States v. Vascular Solutions, Inc...Judge Lamberth charged the jury...The case involves allegations that...a medical device company and its president, engaged in an unlawful off-label marketing campaign. The government’s superseding indictment alleged that the defendants engaged in a criminal conspiracy to violate the Federal Food, Drug, and Cosmetic Act, and committed four counts of selling misbranded medical devices...After deliberating for one day, the jury came back with a verdict of "not guilty" on all counts for both the company and its CEO...FDA’s ability to restrict speech that is truthful and not misleading is limited...FDA has long stated that the dissemination of information about unapproved uses can be important for medical professionals, and so long as the information is distributed according to certain guidelines...promotional speech itself would not be evidence of misbranding so long as the speech was solely truthful and not misleading. This position is consistent with a growing trend among courts to find that truthful and not misleading promotional materials may be distributed by a company without violating the misbranding provisions of the FDC Act...given the growing willingness of companies to challenge FDA’s regulation of off-label promotion, their success in doing so, and court decisions indicating...an unapproved use does not violate the misbranding provisions...DOJ and FDA must carefully consider how to proceed in bringing charges of off-label promotion.
- The State of Provider Status: An Update for Pharmacy Students (pharmacytimes.com)
As the pharmacy landscape shifts and evolves, pharmacists across the country continue to work toward a common and crucial goal: gaining legislative recognition as health care providers...Gaining provider status is a complex and multifaceted objective, but at its heart is the exclusion of pharmacists from the Social Security Act. Exclusion of pharmacists from the SSA prevents many state and private health care plans from compensating pharmacists for patient care services...the omission of pharmacists from the SSA also creates barriers for Medicare beneficiaries who seek to utilize these services in outpatient settings...While provider status efforts are crucial to the pharmacy profession, they’re equally important to patients...Gaining ground in the states...a number of state laws passed in 2015 have given advocates much to celebrate.
- North Dakota Governor Jack Dalrymple signed into law 4 bills that expanded the role of pharmacists in the Peace Garden State and recognized them as health care providers...
- ...Washington Governor Jay Inslee’s signing of SB 5557...The first bill in the country to require the inclusion of pharmacists in health insurance provider networks...amends the state’s Every Category of Health Care Providers law, which obliges commercial health plans to include every category of health care provider within an individual’s participating provider network.
- ...Oregon governor Kate Brown signed HB 2028 into law...bill permits pharmacists to receive reimbursement for performing clinical pharmacy services, enabling them to more fully use their skills and knowledge to treat patients.
- ...the federal arena...federal recognition remains the primary goal for many proponents of provider status...a proposed bill has given advocates hope that such a victory is well within reach...the Pharmacy and Medically Underserved Areas Enhancement Act would amend the SSA to cover pharmacists’ services under Medicare Part B, but only if these services are provided in areas of the country that the Health Resources Services Administration defines as medically underserved areas...The bill is awaiting approval...
Pharmacy students are the future of the profession and...they will be the ones most impacted by provider status...Earning legislative recognition as health care providers will ensure that the next generation of pharmacists is able to treat patients to the full extent of their knowledge and abilities...
- Complaints warrant checkups on doctors (reviewjournal.com)
The Nevada Board of Medical Examiners had a backlog of 525 complaints at the start of 2015. An additional 1,078 complaints were filed last year...By the end of the year, 570 complaints were pending...only 19 medical doctors and physician assistants were publicly disciplined last year...How can a board that's falling behind ever erase that backlog and fulfill its duty to discipline bad medical doctors?...Executive Director Edward Cousineau said Wednesday that the office is making headway and that the situation not as bleak as the numbers suggest...
- State oversight of compounding pharmacies varies dramatically (statnews.com)
Amid ongoing safety concerns over compounding pharmacies, a new analysis finds state oversight is a spotty patchwork of regulations, raising questions about the ability to protect the public health.
- Only about half of the states require compounding pharmacies that make sterile medicines, which are injected or infused into the body, to fully comply with recognized quality standards.
- 60 percent of the states do not require compounding pharmacies to report serious adverse events and reactions related to sterile compounding...
- 16 states reported they do not track compounding pharmacy activity at all.
- 28 states allow traditional compounding pharmacies as opposed to those that make large amounts of medicines for hospitals to provide drugs without prescriptions for individual patients. This practice conflicts with??federal law.
- nine states do not plan on taking any action, such as requiring compounders to register with the FDA or disciplining these businesses.
- 53 percent of the states conduct annual routine inspections for in-state pharmacies that perform sterile compounding.
- any issues discovered during an inspection, 79 percent of the states requires a written response from the pharmacy describing how the issues were addressed,
- 67 percent also need an additional on-site inspection to verify compliance.
- one-third of the states do not perform on-site follow-up inspections to verify needed changes.
- Most of the states...have the authority to issue cease-and-desist orders, but 70 percent also said they were unable to mandate a recall of compounded drugs or were unsure of their explicit authority.
- Biopharmaceutical Innovation: Antibody drug conjugates (catalyst.phrma.org)
Imagine new medicines that effectively fight cancer, but may result in fewer side effects thanks to more accurate targeting of tumor cells. Today, PhRMA released a new video that highlights these promising new therapies called antibody drug conjugates, or ADCs...represent a continuing shift in the cancer treatment landscape toward personalized medicines that more accurately attack specific targets fueling cancer cell growth while leaving more healthy cells unharmed...You can think of them as smart bombs, basically. Precision weapons against cancer...which may provide patients the same level of benefits of standard chemotherapy without some of the side effects that often accompany such treatments...
- State tax on medical devices under fire (kolotv.com)
Devices like C-PAP machines or oxygen tanks are commonplace in some households. Often, patients leave the hospital and are told they need a medical device to help them throughout the home. That's where occupational therapist Leslie Sargent comes into play. She used to visit homes to make sure the patient was safe..."When I was working in home health, a lot of them couldn't afford the equipment at that time," says Sargent...Such practices...are only going to become more common in Nevada after a medical devices tax went into effect in January 2016. Essentially a sales tax, patients are now being taxed on devices that can be used on newborns all the way to hospice patients... Doug Bennett, Chair of the Board of Bennett Medical Services...along with 35 others statewide, is circulating a petition to have voters decide on the medical devices tax in November 2016. He says they are already halfway through getting the required signatures they need to get the measure on the ballot...If it ends up on the 2016 November ballot, and passes, voters will have to approve it again in 2018.
- Roseman’s RN to BSN Program Helps Nurses Achieve Educational Goals (blog.roseman.edu)RN to BSN (roseman.edu)
Roseman’s College of Nursing (Roseman University) recently expanded its offering of nursing degree programs with the creation of a 9-month RN to BSN program. The program is designed for nurses with an associate’s degree who desire a Bachelor of Science in Nursing degree...the...new...program is structured to support working nurses in completing their baccalaureate nursing education while continuing their day-to-day responsibilities...The RN to BSN program offers nurses the opportunity to expand their clinical and theoretical skills and knowledge so they are better positioned to advance in the profession...Roseman University utilizes a block curriculum where students take only one class at a time, focus intently on that content area, and master the content before proceeding to the next block or course. The RN to BSN program consists of eight blocks each taught online by expert faculty with a myriad of clinical, educational and professional backgrounds. The program also includes two one-week, on-campus residencies in Henderson...
- Can PhRMA’s New Boss Help Change The Industry’s Image? (forbes.com)
The reputation of the pharmaceutical industry continues to plummet. A day doesn’t go by without seeing at least one negative news story about... drug pricing...stories about how unaffordable drugs are or about how a family has gone into bankruptcy as a result of paying for a lifesaving medication...millions of dollars paid in fines by companies for the illegal detailing of drugs... Companies continue to be dogged by accusations of hiding clinical data...Direct-to-consumer ads are also a lightning rod...It’s not a happy time for the industry...The industry’s trade association, the Pharmaceutical Research and Manufacturers of America is charged with representing the industry on a host of issues, including improving its reputation...Well, PhRMA has a new leader, Mr. Stephen J. Ubl... he couldn’t have picked a more difficult time to assume the mantel of industry spokesperson. If there is one issue...it is that the pharmaceutical industry needs to be reined in, particularly with respect to drug prices. There couldn’t be a bigger bullseye on the pharmaceutical industry...Mr. Ubl has the opportunity to change the tone of the current pricing debate as well as the other issues that impact the pharmaceutical industry’s reputation...Hopefully, he can start to turn the tide and begin to bring the industry back to the esteem that it enjoyed twenty years ago.
- New mobile clinic will bring health care to patients (reviewjournal.com)
...for some low-income people, having transportation to a medical facility to receive treatment has been a major obstacle. So Southwest Medical Associates, in partnership with Health Plan of Nevada and Sierra Health and Life, revisited the idea of taking medical professionals to the people..."Medicine on the Move," and it's a 45-foot state-of-the-art mobile medical center built on a custom-designed Peterbilt truck frame. It is scheduled to hit the road sometime in mid-May with the primary objective of serving Medicaid patients at homeless shelters, churches, community centers and some businesses whose employees are enrolled in Health Plan of Nevada or Sierra Health and Life medical benefit plans...The mobile medical center is equipped with seemingly everything, and in many cases, much more than what one would find in his or her own doctor's office. The radiology suite features a digital mammography unit, portable ultrasound machine, X-ray unit and four refrigerators and a freezer for storing vaccines. Patients entering the mobile facility will be able to sit in a comfortable spa-like lobby before being taken to one of two private exam rooms...The onboard staff will consist of two medical assistants, two licensed nurse practitioners and one or two providers/doctors as needed, and a radiology technician...Annual physicals, immunization shots, OB/GYN exams, lab tests, pediatric care and wellness appointments will be offered..."As a native Nevadan, I've witnessed the changes and challenges we've faced over the years with health care in Southern Nevada," McBeath (Dr. Robert McBeath) said. "And I believe that this partnership with Health Plan of Nevada and Sierra Health and Life will help us to close the gap and improve access to quality health care in our community."...
- Physician Assistant Program coming in 2017 (medicine.nevada.edu)Physician Assistant Program - Master of Physician Assistant Studies (Proposed) (medicine.nevada.edu)
New master’s will help grow number of healthcare professionals...As our community prepares for significant population growth...the University of Nevada School of Medicine and Renown Health are continuously working together to combat the shortage of healthcare providers in our region...latest effort will be seen in 2017 with the start of a new Master of Physician Assistant program. Renown Health will be an integral partner...committing $500,000 to help kick-start the program as well as providing the expertise of Renown providers and...training sites for future Physician Assistants…This full-time program will last 27 months and include academic and clinical skills courses as well as supervised clinical practice. Students are required to have at least 2,000 hours of healthcare experience before applying and because there is no residency needed after graduation, they can immediately begin working...upon completion of the program...the first PA class would begin in June 2017 on the University's Redfield Campus and the first 24 graduates will be seen in fall 2019.