FDA long-awaited guidelines for stem cell treatments protect emerging Regenerative Medicine field
In a move aimed at encouraging the emerging field of regenerative medicine while also protecting patients from dangerous products, the U.S. Food and Drug Administration (FDA) on Wednesday issued guidelines for exempting certain cell and tissue treatments from the costly drug approval process.
The new policy sets out criteria for using biological products without formal FDA approval. The cells or tissues must come from the patient being treated; be used for the same function they perform naturally in the body; and be “minimally manipulated.” The FDA believes such products pose a low risk of harm.
FDA Guidelines emphasize the following:
“Regenerative medicine is a complex and rapidly evolving field. Accordingly, FDA will continue to reassess its application of the HCT/P regulatory framework, including the minimal manipulation and homologous use criteria in 21 CFR 1271.10(a), as additional scientific evidence emerges in this field.”
“FDA intends to focus enforcement actions on products with higher risk, taking into account factors such as whether the product is for non-autologous (allogeneic) use and the route and site of administration.
For example, actions related to products with routes of administration associated with a higher risk (e.g., those administered by intravenous injection or infusion, aerosol inhalation, intraocular injection, or injection or infusion into the central nervous system) will be prioritized over those associated with a lower risk (e.g., those administered by intradermal, subcutaneous, or intra-articular injection). HCT/Ps that are intended for non-homologous use, particularly those intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions, are also more likely to raise significant safety concerns than HCT/Ps intended for homologous use because there is less basis on which to predict the product’s behavior in the recipient, and use of these unapproved products may cause users to delay or discontinue medical treatments that have been found safe and effective through the New Drug Application or BLA approval processes.” (pages 21 and 22 of guidelines)
The FDA said manufacturers will have 36 months to determine whether their products qualify for exemptions from the drug-approval process, or must apply to begin that process
Read more:
|
|
Register Now
The American Society of Interventional Pain Physicians will hold its 20th Annual Meeting March 15-17, 2018 in Orlando, Florida at
Marriott Orlando World Center.
March 15, 2018
Raj-Racz Distinguished Lecture Series
- Arnold Caplan, PhD Mesenchymal Stem Cells: Today, Tomorrow, and Future of Pain Management
- Laxmaiah Manchikanti, MD: Evidence Synthesis in IPM: Evolution of EBM or Death of Expertise and Truth
Afternoon:
- Jerome Adams, MD, Surgeon General: Addressing National Opioid Epidemic
- Vanila Singh, MD: Update on Committee on Pain Management Best Practices Inter-Agency Task Force
- Breakout sessions: Resident/Fellow Section, Imaging for Interventionalists, Regenerative Medicine Guidelines, Concepts in IPM
March 16, 2018
Manchikanti
Distinguished Lecture Series
- Robert Laszewski: State of Health Care in the US: Past, Present, and Future
- Congressman Ed Whitfield: Health Care Advocacy: ASIPP Involvement with Grass Roots Advocacy
- Sen. Tim Hutchinson: Health Care Reform: A View from Washington
- DISCUSSION FORUM
- Panel: Robert Laszewski, Ed Whitfield, Tim Hutchinson, Laxmaiah Manchikanti, MD, Amol Soin, MD
Breakout Sessions: Compliance, Billing and Coding; Role of Marijuana in IPM Practice: Pros and Cons; Managing Physician Burnout; Endoscopic Decompression; Opioids
Breakout sessions in the morning and in the afternoon.
March 17, 2018
Senator Cassidy and other keynotes and 8 panel discussions on various subjects of interventional pain management until 5 pm.
|
|
Start Planning NOW!
ASIPP Abstract Submission for 2018 Annual Meeting is Open
This year, we will be making significant changes to the Abstract and Poster Sessions. Submissions will be in two categories: Resident/Fellow and Physician. Selected posters will be on display for all meeting participants during all breaks and meal times.
The Abstract Committee will select the top 25 for publication in Pain Physician and of those 10 will be selected for Abstract presentation and judging during the Annual Meeting. The top 3 will receive cash prizes.
|
|
Separating side effects could hold key for safer opioids
Opioid pain relievers can be extremely effective in relieving pain, but can carry a high risk of addiction and ultimately overdose when breathing is suppressed and stops. Scientists have discovered a way to separate these two effects — pain relief and breathing — opening a window of opportunity to make effective pain medications without the risk of respiratory failure. The research, published today in Cell, was funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.
Opioid medications suppress pain by binding to specific receptors (proteins) in the brain; these same receptors also produce respiratory suppression. However, the way these receptors act to regulate pain and breathing may be fundamentally different. Studies using mouse genetic models suggest that avoiding one particular signaling pathway led to more favorable responses to morphine (pain relief without respiration effects). The investigators then explored if they could make drugs that would turn on the pathways associated with pain relief and avoid the pathways associated with respiratory suppression.
|
|
CMS Rule on Part B Drugs Could Lead to Steep Payment Cuts for Some Specialists
On November 2, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that could result in steep payment reductions for physicians of certain specialties in 2018.
1 Under the rule, payment adjustments based on the Merit-Based Incentive Payment System (MIPS) will be calculated differently starting in the new year. This could result in significant payment adjustments for specialists who administer a greater quantity of Part B drugs.
“For most types of physicians, these payment adjustments would only range between ±5%, as provided for under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA),” according to a press release from Avalere Health, a healthcare consulting firm based in Washington, DC.
1 For certain specialists, however, payments may increase or decrease by up to 16% in 2018, with further adjustments to follow in 2020, after MIPS has reached full implementation.
|
|
Interventional Pain Management Reports
is an Open Access online journal, a peer-reviews journal dedicated to the publication of case reports, brief commentaries and reviews and letters to the editor. It is a peer-reviewed journal written by and directed to an audience of interventional pain physicians, clinicians and basic scientists with an interest in interventional pain management and pain medicine.
Interventional Pain Management Reports
is an official publication of the American Society of Interventional Pain Physicians (ASIPP) and is a sister publication of
Pain Physician
.
Interventional Pain Management Reports Interventional Pain Management Reports
is an open access journal, available online with free full manuscripts.
The benefits of publishing in an open access journal that has a corresponding print edition journal are:
- Your article will have the potential to obtain more citations.
- Your article will be peer-reviewed and published faster than other journals.
- Your article can be read by a potentially much larger audience compared with traditional subscription-only journals.
- Open Access journals are FREE to view, download and to print.
So submit today your:
- Case Reports
- Technical Reports
- Editorials
- Short Perspectives
|
|
Reformed HIPAA Regulations Needed to Better Facilitate Use of Patient Engagement Tools
According to a recent article published in the
New England Journal of Medicine
, reformed privacy and security requirements under the Health Insurance Portability and Accountability Act (HIPAA) could allow better access to increasing patient engagement technology.
Ameet Sarpatwari, JD, PhD, and Niteesh K. Choudhry, MD, PhD from Brigham and Women's Hospital and Harvard Medical School in Boston, Massachusetts, argue that patient engagement might improve if providers implemented a system that required patients to elect to receive current privacy and security standards for sharing protected health information. However, such a change would require amending
HIPAA regulations
.
|
|
Benzodiazepines increase mortality in persons with Alzheimer’s disease
Benzodiazepine and related drug use is associated with a 40 per cent increase in mortality among persons with Alzheimer’s disease, according to a new study from the University of Eastern Finland. The findings were published in the International Journal of Geriatric Psychiatry.
The study found that the risk of death was increased right from the initiation of benzodiazepine and related drug use. The increased risk of death may result from the adverse events of these drugs, including fall-related injuries, such as hip fractures, as well as pneumonia and stroke.
The study was based on the register-based MEDALZ (Medication Use and Alzheimer’s Disease) cohort, which includes all persons diagnosed with Alzheimer’s disease in Finland during 2005-2011. Persons who had used benzodiazepines and related drugs previously were excluded from this study, and therefore, the study population consisted of 10,380 new users of these drugs. They were compared with 20,760 persons who did not use these drugs.
University of Eastern Finland
Press release, 20 November 2017
|
|
Drug Test Documentation and Coding Webinar
Improve Your Documentation and Billing for Narcotic Management and Survive Audit
Newspapers and the internet blast the headlines when pain management practices and providers are the subjects of legal action related to narcotic management. In addition, physicians, especially those with in-house labs, have been prosecuted based on statistical analysis of their claims submission which indicated overbilling for urine drug testing.
Will your practice survive an audit of this highly scrutinized aspect of pain management or do your current records put you at risk? With governmental and media’s focus on the “opioid crisis”, compliant documentation and billing for the provision of narcotics is essential.
Webinar Fee: $185
Webinar Date: December 6, 2017
Time: 11am-12:30pm CST
Speaker: Judith Blaszczyk, RN, CPC, ACS-IPM, ICDCT-CM
*This program has been submitted to the American Academy of Professional Coders (AAPC) for 1.5 continuing education hours. Granting of prior approval in no way constitutes endorsement by the AAPC of the program content or the program sponsor.
|
|
FDA Expresses Safety Concern Over Kratom
The Food and Drug Administration (FDA)'s Commissioner Scott Gottlieb, MD, has issued a statement regarding the deadly risks associated with the botanical substance, kratom.
Kratom has grown in popularity in the US, with circulating claims of it being a safe treatment with a range of healing properties. The FDA is aware that individuals have been using kratom to treat pain, anxiety, and depression, as well as for recreational purposes for its euphoric effects.
The
herbal product
has been shown to exert similar effects as opioids, carrying with it similar risks of abuse and addiction. Kratom is categorized as a controlled substance in 16 countries and is banned in multiple states including Alabama, Arkansas, Indiana, Tennessee, and Wisconsin.
|
|
Opioid Manufacturers Providing Training for Clinicians
In an effort to halt the ongoing opioid addiction crisis, US regulators are requiring manufacturers to provide extensive training to doctors, according to a report published by the Associated Press.
Scott Gottleib, MD, commissioner of the US Food and Drug Administration, noted in a recent blog post that the FDA had informed 74 manufacturers of immediate-release opioids, including hydrocodone/acetaminophen and oxycodone/acetaminophen, that their drugs would be subject to these requirements. However, physicians will not be required to undergo training.
|
|
FDA Approves First Drug in US With Digital Ingestion Tracking System
The first drug in the United States with a digital ingestion tracking system has been approved by the US Food and Drug Administration.
Abilify MyCite consists of aripiprazole tablets with an embedded sensor in each that sends a message to a wearable patch when the medication been taken. This allows the patients to track medication ingestion via smartphone, and they can also permit their physicians and caregivers to access the information through a web-based portal.
Abilify MyCite hasn't been proven to improve patient compliance with a
treatment regimen
, the FDA said in a news release. And the drug should not be used in an attempt to track real-time ingestion since detection could be delayed, the agency added.
|
|
April 18-22, 2018
GSIPP 2018 Annual Meeting
Georgia Society of Interventional Pain Physicians
Thursday, April 18, 2018 - Sunday, April 22, 2018
The Ritz Carlton Reynolds, Lake Oconee
July 19-22, 2018
FSIPP 2018 Annual Meeting, Conference, and Trade Show
Florida Society of Interventional Pain Physicians
One South County Road, Palm Beach, FL 33480
|
|
|
|
|
|
|
