In the News

Popular Nasal Decongestant Doesn't Actually Relieve Congestion, FDA Experts Say

Associated Press | By Matthew Perrone

WASHINGTON — The leading decongestant used by millions of Americans looking for relief from a stuffy nose is likely no better than a dummy pill, according to government experts who reviewed the latest research on the long-questioned drug ingredient.

Advisers to the Food and Drug Administration voted unanimously on Tuesday against the effectiveness of the ingredient found in popular versions of Sudafed, Allegra, Dayquil and other medications sold on pharmacy shelves.

"Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine," said Dr. Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine.

The FDA assembled its outside advisers to take another look at phenylephrine, which became the main drug in over-the-counter decongestants when medicines with an older ingredient — pseudoephedrine — were moved behind pharmacy counters. A 2006 law had forced the move because pseudoephedrine can be illegally processed into methamphetamine.

Does evidence show a benefit?

If the FDA follows through on the panel's recommendations, Johnson & Johnson, Bayer and other drugmakers could be required to pull their oral medications containing phenylephrine from store shelves. That would likely force consumers to switch to the behind-the-counter versions of the pills or to nasal sprays and drops that contain phenylephrine, which are not under review.

This week's two-day meeting was prompted by researchers at the University of Florida, who petitioned the FDA to remove phenylephrine products based on recent studies showing they failed to outperform placebo pills in patients with cold and allergy congestion. The same researchers also challenged the drug's effectiveness in 2007, but the FDA allowed the products to remain on the market pending additional research.

That was also the recommendation of FDA's outside experts at the time, who met for a similar meeting on the drug in 2007.

This time, the 16 members of the FDA panel unanimously agreed that current evidence doesn't show a benefit for the drug.

"I feel this drug in this oral dose should have been removed from the market a long time ago," said Jennifer Schwartzott, the patient representative on the panel. "Patients require and deserve medications that treat their symptoms safely and effectively and I don't believe that this medication does that."…

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Moderna Says Updated COVID Vaccine is Effective Against Newer Variant

Reuters | By Patrick Wingrove

WASHINGTON — Moderna on Wednesday said clinical trial data showed its updated COVID-19 vaccine will likely be effective against the highly mutated BA.2.86 subvariant of the coronavirus that has raised fears of a resurgence of infections.

The company said its shot generated an 8.7-fold increase in neutralizing antibodies in humans against BA.2.86, which is being tracked by the World Health Organization and the U.S. Centers for Disease Control and Prevention.

"We think this is news people will want to hear as they prepare to go out and get their fall boosters," Moderna's head of infectious diseases Jacqueline Miller said, adding that the data should also help reassure regulators.

The CDC has previously indicated that BA.2.86 may be more capable of causing infection in people who previously had COVID or were vaccinated with previous shots. The Omicron offshoot carries more than 35 mutations in key portions of the virus compared with XBB.1.5, the dominant variant through most of 2023 and the target of the updated shots.

Moderna said it had shared the new finding on its vaccine with regulators and submitted it for peer-review publication. The retooled shot has yet to be approved by the U.S. Food and Drug Administration but is expected to be available later this month or in early October.

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Input Needed: Proposed Regulations for Adult Protective Services Programs

ACL is seeking input on a proposed rule to establish the first-ever federal regulations for adult protective services (APS) programs. Instructions for submitting comments and registering for an informational webinar can be found on ACL.gov and at the bottom of this announcement.

APS programs across the country support older adults and adults with disabilities who experience, or who are at risk of, abuse, neglect, self-neglect, or financial exploitation. APS programs investigate reports of maltreatment; conduct case planning, monitoring, and evaluation; and provide, or connect people who have experienced maltreatment to, a variety of medical, social service, economic, legal, housing, law enforcement, and other protective, emergency, or support services to help them recover. Over the past decade, ACL has led federal efforts to support the critical work of APS programs through a variety of initiatives.

First-Ever Federal Regulations for APS

The proposed rule aims to improve consistency and quality of APS services across states and support the national network that delivers APS services, with the ultimate goal of better meeting the needs of adults who experience, or are at risk of, maltreatment. To those ends, the proposed rule: 

  • Establishes common definitions for the national APS system to improve information sharing, data collection, and standardization between and within states.
  • Requires state APS systems to develop policies and procedures, consistent with state law, for coordination and sharing of information to facilitate investigations with other entities, such as state law enforcement agencies and state Medicaid agencies.
  • Requires state policies and procedures to be person-directed and based on concepts of least restrictive alternatives.
  • Establishes requirements for data collection, retention, and reporting. 
  • Establishes requirements for mandatory staff training and ongoing education on core competencies for APS staff and supervisors.

We have created a fact sheet with highlights of key provisions of the rule, and the full text of the proposed rule can be found on the Federal Register website.

Input Needed

The proposed rule is the culmination of many years of engagement with stakeholders from APS and long-term care ombudsman programs, as well as disability advocates, from across the country. It also reflects input received through several listening sessions, extensive research, and analysis of data from a 2021 survey of 51 APS systems, ACL’s National Adult Maltreatment Reporting System, and policy profiles from APS programs in all states and territories.

ACL now seeks feedback on the proposed rule from all who are interested in improving implementation of APS programs and services. Input from the aging and disability networks and the people served by APS programs is particularly crucial.

Comments will be accepted for 60 days, beginning when the proposed rule is officially published in the Federal Register (which currently is scheduled for Tuesday, September 12). Instructions for commenting, along with the comment deadline, can be found in the Federal Register notice and on ACL’s website.

An informational webinar will be held on Monday, September 18, at 11:30 AM ET. Advance registration is required.  
 

ACHH Graduate Virtual Journal Club

When: Thursday, September 14, 2023 | 7:00pm - 8:30pm Eastern 

The ACHH faculty have worked with the APTA Home Health Board to initiate a journal club exclusively for the PT and PTA graduates of the ACHH certification program.

The FREE ACHH journal club will take place three times a year on the second Thursday of January, May, and September, from 7:00pm – 8:30pm EST.  The first 30 minutes will be a happy hour of networking and discussion and then one member will lead a guided journal club.  Participation in the club will carry points towards recertification, with one point for each club attended, to a maximum of 5, and 3 points for the individual leading the discussion.  The club will be held virtually, and details and the link will be sent by the section to all graduates of the program.  It is planned that the topics will rotate through different major areas such as neurological, cardiopulmonary, musculoskeletal and issues specific to PTAs. 

The next event will be on Thursday, September 14, 2023. Any volunteers to lead journal discussions in the subsequent meetings will be appreciated. Remember - 3 points will be awarded towards your ACHH Certification Renewal if you volunteer to lead these discussions. If interested, please email us at [email protected].

ACHH program graduates, click here to register for free! 
 

APTA Comments to CMS on CY 2024 HH PPS Proposed Rule

APTA has submitted extensive comments to CMS on CY 2024 HH PPS Proposed Rule, which were developed with input from members of the Post-Acute Care Workgroup.

Please click here to read the full letter that was submitted. 
 
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