FDA to Host Meeting on Opioid Prescribing Information Implementation
On January 30, 2018, the United States Food and Drug Administration (FDA) will host a public meeting entitled, “Opioid Policy Steering Committee: Prescribing Intervention – Exploring a Strategy for Implementation.” The FDA hopes to receive stakeholder input on how the agency can improve the safe use of opioid analgesics by curbing overprescribing to decrease the occurrence of new addictions and limit the misuse and abuse of opioids, under the FDA Risk Evaluation and Mitigation Strategy (REMS).
Recent studies suggest that prescriptions for opioid analgesics are frequently dispensed for a number of tablets that exceed...
Source: Policy and Medicine - December 20, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Report Issued on Third Annual Joint Accreditation Leadership Summit
On June 9, 2017, the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) participated in the third annual Joint Accreditation Leadership Summit. During this Summit, interprofessional continuing education (IPCE) professionals discussed various challenges and opportunities related to IPCE.
The Summit was conducted in three parts and included discussion about publishing research and disseminating success stories about IPCE; case examples of research in action; and “hot topics” in IPCE, with atte...
Source: Policy and Medicine - December 19, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
FDA Issues Two Federal Register Notices on Prescription Drug Promotion
On December 11, 2017, the United States Food and Drug Administration (FDA) published two Federal Register notices regarding prescription drug promotion from the FDA’s Center for Drug Evaluation and Research (CDER) Office of Prescription Drug Promotion (OPDP).
Final Guidance on Promotional Labeling
The first notice announces the FDA’s Final Guidance on product name placement, size, prominence, and frequency in promotional labeling and advertisement for prescription drugs (human and animal), including prescription biological products. The FDA believes that the disclosure of the product name in promotional materials is ...
Source: Policy and Medicine - December 18, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
PhRMA Releases Report on Financial Flow in Pharmaceutical Industry
In late November, the Pharmaceutical Research and Manufacturers Association (PhRMA) released a new report examining how money flows through the supply chain and how that impacts what patients pay at the pharmacy. According to the report, this system often creates incentives for pharmacy benefit managers (PBMs) to opt for medicines with higher list prices and higher rebates.
The report provides illustrative examples for three patients to not only provide answers, but also to highlight the fact that there is no one price for medicine. This is because prices paid by wholesalers, pharmacies, pharmacy benefit managers (PBMs), ...
Source: Policy and Medicine - December 15, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Medical Societies Ask Congress to Preserve Patient Access to Critical Part B Therapies
Eleven medical societies – including the American College of Rheumatology, American Academy of Ophthalmology, American Society of Clinical Oncology and American Urological Association – are urging congressional leaders to preserve patients’ access to critical Part B drug treatments by preventing the Centers for Medicare & Medicaid Services (CMS) from penalizing physicians for providing high-quality care.
The societies recently sent a joint letter to the chairs and ranking members of the Senate Finance Committee, the House Ways & Means Committee, and the House Energy & Commerce Com...
Source: Policy and Medicine - December 14, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
FDA Issues Guidance on Real-World Evidence for Medical Devices
Earlier this year, the United States Food and Drug Administration (FDA) finalized guidance on the use of real world evidence to support regulatory decision-making for medical devices. The final guidance follows a July 2016 draft guidance on the topic in which the FDA discussed potential uses of real world data and the various factors evaluated to determine whether that data can support a regulatory decision. The FDA believes that this guidance is a “cornerstone” of its strategic priority to build a national evaluation system for health technology.
The final guidance includes clarity as to what it means for companies m...
Source: Policy and Medicine - December 13, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Alliance for Continuing Education in the Health Professions Annual Conference
January 20, 2018 through January 23, 2018, the Alliance for Continuing Education in the Health Professions (the Alliance) will hold their 2018 Annual Conference in Orlando, Florida at the Grande Lakes hotel.
The Annual Conference boasts four days of education and networking events, starting off on Saturday, January 20, 2018, with several early morning workshops followed by afternoon member section meetings. Closing out the first day are the Opening Night Awards Dinner and the President’s Dessert Reception.
On Sunday, January 21, 2018, attendees will hear the Annual State of the Alliance, followed by a keynote speech on...
Source: Policy and Medicine - December 12, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Senate Appropriations Committee Takes on the Opioid Epidemic
On December 5, 2017, the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing to discuss the opioid epidemic and the possible role that Congress could play in the prevention, treatment, and recovery.
Senator Roy Blunt, the Subcommittee Chairman, opened the hearing by discussing the fact that overdose related deaths outnumber the deaths at the peak of the AIDS/HIV epidemic. Overdose deaths have also overtaken automobile accident fatalities to become the number one cause of accidental death in the United States. Senator Blunt also spoke about the three propos...
Source: Policy and Medicine - December 12, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
CMS Institutes New Medicaid Policy Regarding Opioids
Recently, the Centers for Medicare & Medicaid Services (CMS) announced a new policy to allow states to design demonstration projects that increase access to treatment for opioid use disorder (OUD) and other substance use disorders (SUD). This new demonstration policy responds to President Trump's directive and provides states with greater flexibility to design programs that improve access to high quality, clinically appropriate treatment. In addition to the new policy, CMS announced an immediate approval of both New Jersey and Utah’s demonstration waivers under the new policy.
Through this updated policy, states wil...
Source: Policy and Medicine - December 11, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Drug Pricing Report Released by NASEM
The most recent example of drug marketing being caught in the crossfire of the drug pricing debate can be found in a report by the National Academies of Sciences, Engineering and Medicine, which included suppression of consumer marketing in a set of recommendations on how to lower the cost of prescription drugs for patients. One recommendation was that advertising costs should no longer be considered tax deductible as a business expense.
The report offers eight recommendations with twenty-seven different actions for their implementation (a sample of actions in each area appears below) to improve the affordability of presc...
Source: Policy and Medicine - December 8, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
HCEA To Host Webinar on New International Ethics Rules
On Wednesday, December 13, 2017, the Healthcare Convention & Exhibitors Association (HCEA) will present a webinar entitled: “Preparing for the 2018 Ethical MeDTECH, APACMed and China Codes Impact on International Attendee Participation at US Meetings.”
As we have previously written about, beginning January 1, 2018, medical device companies in various regions of the world will no longer be able to directly sponsor participant’s travel to educational meetings. The Accreditation Council for Continuing Medical Education (ACCME) and other organizations have applauded this effort, as it furthers the independence of ed...
Source: Policy and Medicine - December 7, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Congress Taking New Approach to Opioid Epidemic
Recently, Representative Bob Latta introduced a bill into the United States House of Representatives. The bill, known as the Indexing Narcotics, Fentanyl and Opioids (INFO) Act, is intended to help create a public electronic database of information and strategies to combat the opioid crisis. The information in the database would be used to help federal, state, and local officials develop the most effective strategies to prevent addiction, treat those that are addicted, and keep prescription drugs from falling into the wrong hands. The INFO Act would also track federal funding being used to combat the epidemic.
The bill re...
Source: Policy and Medicine - December 7, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
FDA Releases Guidelines for Physicians Using Investigational Drugs in Emergency Situations
In a recent Manual of Policies and Procedures (MAPP), the FDA laid out the process by which physicians can access an investigational drug for treatment in an individual patient in an emergency situation, both during and after normal business hours.
MAPP Specifics
The MAPP describes the policies and procedures established in the Center for Drug Evaluation and Research (CDER) for managing and processing applications for individual patient expanded access for emergency use (or, emergency investigational new drug applications (EINDs)) for licensed physicians seeking access to an investigational drug for treatment use in an i...
Source: Policy and Medicine - December 6, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
FDA Offers Draft Guidance on E-Submissions of REMS Documents
The FDA recently released draft guidance describing how FDA plans to implement the requirements for the electronic submission of Risk Evaluation and Mitigation Strategies (REMS) documents in certain submissions under new drug applications, abbreviated new drug applications and biologics license applications.
FDA Comments on Stakeholder Feedback
In the guidance, FDA describes three years of engagement and analysis of stakeholder feedback regarding REMS standardization. The agency’s findings were published as a report: “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS).” As the report desc...
Source: Policy and Medicine - December 5, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Can CME Help the Opioid Epidemic?
Conclusion
Therefore, POLITICO and the stakeholders made a policy recommendation focused on educating providers. They suggest that education on both pain management and addiction has to start in medical school. However, early education is not enough unless it is supplemented by CME. The medical field should continue the progress it has made increasing education around proper prescribing, but it should increase its efforts by evaluating doctors in some meaningful way such as on licensing exams or through CME.
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Source: Policy and Medicine - December 4, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
