Tag:FDA
FDA-USPTO Collaboration and Bipartisan Efforts to Lower Drug Prices
The Food and Drug Administration (FDA) has partnered with the Patent and Trademark Office (USPTO) to address the high cost of prescription drugs. While the FDA possesses the authority to approve generic, lower cost drugs, the USPTO has an important and symbiotic role in bringing affordable drugs to market by blocking anti-competitive patent extensions. FDA-USPTO collaboration has gained congressional support and is the subject of key pieces of new legislation.
The Discriminatory Policies against Gay and Bisexual Men that are Fueling the National Blood Crisis
This past January, the American Red Cross announced that the United States was facing its worst blood shortage in over a decade, posing a significant risk to patient care and causing doctors to make difficult decisions in determining which patients should be prioritized for blood transfusions given the dwindling supply. The staggering decrease in blood and platelet donations can be attributed to the global COVID-19 pandemic driving up the need for donations and the hesitancy people have had to leave their homes over the past two years. Even in this desperate time of need for blood, gay and bisexual men in America are still prevented from donating because of discrimination.
FDA’s Proposed Global Regulatory Harmonization for Medical Devices
On February 23, 2022, the Food and Drug Administration (FDA) published a proposed regulation to amend current manufacturing practice requirements of the Quality System Regulation (QSR) (21 CFR Part 820). The FDA first announced such harmonization in 2018, however COVID-19 delayed the proposal. The FDA seeks to align Part 820 more closely with the international specific standard for medical device quality management systems set out by the International Organization for Standardizations (ISO) 13485. According to the FDA, such “harmonization should provide patients more efficient access to necessary devices, leading to improvements of life quality of the consumers.” Part 820 is part of the current mandatory regulations that ensure that all medical devices created and developed within the US market are safe. ISO 13485 is the international standard for a quality management system for medical devices required by certain countries. Therefore, any manufacturer that sells outside the US will likely need to be ISO 13485 certified. With the implementation of this new amendment, manufacturers would be able to assure their products are regulatorily compliant in both the US and international markets.
What the Cluck is Going on? Regulatory Failures Amid a Nationwide Food Poisoning Epidemic
In October 2021, ProPublica published an article about a rare and virulent strain of salmonella infantis outbreak that occurred in May 2018, afflicting at least a dozen people across the country. Many who reported being sick reported that they ate chicken, and federal food safety inspectors found the infantis strain in packaged chicken breasts, sausages, and wings during routine inspections at poultry plants.
What’s the Tea?
When people hear the phrase “regulatory compliance”, they often think about the finance, banking, or tech industry – not the business of loose and pressed leaves. In fact, the tea industry has been on the rise and is projected to reach almost $69 billion by 2027. Within that market, the green tea segment is the highest growth contributor with an estimated $16 billion in 2019 and is projected to reach almost $26 billion by 2027. This leafy market comes with its own set of compliance issues and a potential for growth this year.
Compliance and Aducanumab – How Should Providers Balance FDA and CMS Guidance?
As my colleague at Inside Compliance discussed here in September, the FDA approved Aducanumab for the treatment of Alzheimer’s Disease on June 7, 2021. Aducanumab, marketed as Aduhelm, is intended to reduce beta-amyloid levels. This compound is responsible for forming a “plaque” which inhibits neuron function and eventually triggers neuronal apoptosis (death of neurons). Now, a recent decision by CMS on insurance reimbursement for aducanumab has increased the compliance responsibilities of providers.
Politicizing a Pandemic: Emergency Use Authorizations for COVID-19
The Food and Drug Administration (“FDA”) is one regulatory agency that has been on the forefront of the American fight against COVID-19. Historically, the agency has been highly respected for its success in apolitical operation despite its mission of (1) protecting the public health and (2) innovating in the development of medical products. One of its most important tools in the face of a public health crisis is the once obscure regulatory mechanism called the Emergency Use Authorization (“EUA”). But as public trust in the FDA falters, Americans are surely wondering how effective a protective measure can be when it seems to be used as political ammo.
Johnson & Johnson COVID-19 Vaccine Awaits Authorization from FDA
Recently, the U.S. Food & Drug Administration (“FDA”) announced a scheduled meeting of its Vaccines and Related Biological Products Advisory Committee (“VRBPAC”) to discuss the request for emergency use authorization (“EUA”) for a COVID-19 vaccine from Janssen Biotech Inc. The FDA has just under three weeks to complete its report before the VRBPAC’s meeting to make its recommendation on the vaccine. The review process may be more challenging than the past two reviews for Pfizer and Moderna due to the composition differences and effectiveness.
Running a Restaurant in the Covid Era; So Much Regulation, So Little Guidance.
Americans miss dining out. In fact, surveys indicate that sitting down in a restaurant is the most missed pastime of the Covid-19 pandemic. As the monotony of homebound living grows and already economically fragile restaurants operate at a diminished capacity, patrons and restaurants alike are flouting regulations to get back to normal. Between the pressure of dwindling stimulus loans and eager customers, regulation must be balanced with economic relief to encourage responsible and sustainable reopening.
The New Hope and Frustration for Alzheimer’s Patients
For the first time in about twenty years, the U.S. Food and Drug Administration (FDA) approved a drug to combat the progression of Alzheimer’s. The newly approved drug is manufactured by Biogen and will be called Aduhelm. The FDA granted fast track designation of the drug to speed up access to patients. While Aduhelm will not reverse already developed Alzheimer’s symptoms, it will slow down the advancement of the disease by removing deposits of beta-amyloid, a protein found in early-stage Alzheimer’s patient’s brains.