Tag archives: FDA

COVID-19 Update: First EUA for COVID-19 Vaccine Filing Imminent; CDC Urges Americans Not to Travel for Thanksgiving

On Friday November 20, Pfizer and BioNTech announced they would submit a request to the U.S. Food and Drug Administration (“FDA”) seeking Emergency Use Authorization for their vaccine candidate.  Earlier this week, the companies announced that at the completion of their Phase 3 trial, the vaccine was 95 percent effective.  In addition to the effectiveness, … Continue reading

COVID-19 Update: Progress toward a vaccine candidate

On November 9, Pfizer and its German counterpart BioNTech announced initial clinical results found their coronavirus vaccine candidate to be more than 90 percent effective. Pfizer will wait to seek Emergency Use Authorization (“EUA”) from the US Food and Drug Administration (“FDA”) under Section 564 of the Food, Drug, and Cosmetic Act. Clinical study subjects must … Continue reading

COVID-19 Update: Biopharmaceutical Executives Release Joint Statement on Vaccine

Chief executive officers of nine biopharmaceutical companies signed an unprecedented joint pledge, entitled BIOPHARMA LEADERS UNITE TO STAND WITH SCIENCE, acknowledging the U.S. Food and Drug Administration’s (“FDA”) role in the development of a COVID-19 vaccine, and pledging to: Always make the safety and well-being of vaccinated individuals our top priority. Continue to adhere to … Continue reading

CMS Publishes Proposed Rule on Medicare Coverage for Innovative Technologies 

On September 1, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule that would establish a new Medicare coverage pathway, Medicare Coverage of Innovative Technology (“MCIT”), for medical devices that are designated by the Food and Drug Administration (“FDA”) as breakthrough devices. Under the proposed MCIT pathway, CMS would provide national … Continue reading

HHS Issues Proposed Rule on Good Guidance Practices

On August 20, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a proposed rule that would impose requirements regarding the issuance and reliance on HHS guidance documents. This proposed rule results from the 2019 U.S. Supreme Court decision in Azar v. Allina Health Services (139 S. Ct. 1804). In this case the … Continue reading

COVID-19 Update: FDA Inspections Signal Resumption of Government Enforcement Efforts

On July 10, 2020, the U.S. Food and Drug Administration (FDA) announced it would resume domestic on-site inspections beginning the week of July 20.  Due to the COVID-19 pandemic, the FDA suspended inspections of facilities in March “to help slow the spread of the virus and help flatten the curve of the COVID-19 pandemic.”   To … Continue reading

COVID-19 Update: FDA revokes EUA for malaria drugs used as COVID-19 treatment

On June 15, 2020, the U.S. Food and Drug Administration (FDA) revoked emergency use authorization (EUA) for chloroquine (CQ) and hydroxychloroquine (HCQ).  The FDA found that the criteria for issuance of the EUA are no longer met and “in light of ongoing reports of serious cardiac adverse events and several newly reported cases of methemoglobinemia … Continue reading

COVID-19 Update: FEMA Issues Interim Final Rule Allocating Scarce or Threatened Materials

On April 7, 2020, the Federal Emergency Management Administration (“FEMA”) released a final rule pursuant to the Defense Production Act (“DPA”) and Executive Orders issued by President Trump prohibiting the export of the scarce or threatened materials identified by President Trump on April 3, 2020.  HL Pulse summary is available here.  Specifically, the Executive Order … Continue reading

COVID-19 Update: HHS Letter Permits Hospital Sharing of Ventilators

On March 30, 2020, a letter to hospitals from U.S. Surgeon General Jerome Adams and U.S. Department of Health and Human Services Assistant Secretary for Health Adm. Brett Giroir released Guidelines to Optimize the Use of Mechanical Ventilators permitting the use of a single mechanical ventilator for two patients.  However, this “strategy should only be … Continue reading

COVID-19 Update: Coronavirus Designated a Pandemic by WHO

On Wednesday the World Health Organization declared COVID-19 a pandemic.  WHO Director-General Tedros Adhanom Ghebreyesus stated that “In the days and weeks ahead, we expect to see the number of cases, the number of deaths and the number of affected countries climb even higher.”  In a hearing before the House Oversight and Reform Committee Dr. … Continue reading

FDA Final Rule Amends Definition of “Biological Product”

On February 20, 2020 the U.S. Food and Drug Administration (FDA) published a final rule, revising the regulatory definition of biological products to match the definition Congress agreed to in the Further Consolidated Appropriations Act, 2020.  The changes reflect the FDA’s efforts to remove regulatory hurdles in order to create cheaper versions of biological products, … Continue reading

COVID-19 Update: US Expands Travel Restrictions After First Fatality

On Saturday, the State of Washington announced the first fatality in the United States arising from the coronavirus, with a second announced on Sunday. Washington Governor Jay Inslee has declared a state of emergency.  As of Monday March 2, 2020, there were 89,197 total confirmed cases of COVID-19 worldwide and 3,048 resulting deaths.  U.S. Secretary … Continue reading

FDA publishes new 510(K) guidance

On January 22, 2019, the FDA released nonbinding guidance expanding the Abbreviated 510(k) program used to show the safety and efficacy of medical devices.  A new “safety and performance-based pathway” for certain, well understood device types, may be used by manufacturers to demonstrate substantial equivalency to devices already on the market. Under the 510(k) process, … Continue reading

FDA releases new guidance on off-label promotion

Last week, the U.S. Food and Drug Administration (“FDA”) released two guidance documents that relate to sharing of certain information about drugs and medical devices, including economic information about unapproved products and unapproved uses, as well as information not included in a product’s FDA-approved labeling. These guidance documents are part of broader blueprint published by … Continue reading

FDA releases 2017 enforcement statistics and recall draft guidance

On January 17, 2018, the U.S. Food and Drug Administration (“FDA”) released its 2017 enforcement statistics. Overall, the statistics showed that there were no food importation debarment enforcement actions in the past year. Notably, there were 15,318 warning letters issued, 9,199 products recalled, and 2,945 recall events. There were 12 injunctions, 5 drug product debarments, … Continue reading

FDA relaxes FSMA enforcement

On January 5, 2018, the U.S. Food and Drug Administration (“FDA”) released guidance entitled Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs: Guidance for Industry. The guidance states that FDA will exercise enforcement discretion for certain parts of the Food Safety Modernization … Continue reading

FDA commissioner discusses key policy goals for 2018

On December 14, 2017, the Commissioner of the U.S. Food and Drug Administration (“FDA”), Dr. Scott Gottlieb, posted Looking ahead: Some of FDA’s major policy goals for 2018 on FDA’s blog, FDA Voice, and discussed FDA’s policy agenda published on the Unified Agenda of Federal Regulatory and Deregulatory Actions (“Unified Agenda”), which provides the public … Continue reading

FDA commissioner discusses upcoming guidance to modernize its framework for medical device review

On December 11, 2017, the U.S. Food and Drug Administration (“FDA”) Commissioner, Scott Gottlieb, posted Advancing Policies to Promote Safe, Effective MedTech Innovation on FDA’s blog, FDA Voice and discussed FDA’s plans to modernize its policy framework for the review of new medical devices. These changes will require FDA to make the review process more … Continue reading

OIG rescinds advisory opinion to charity

For the first time, the OIG has rescinded an advisory opinion issued to a charity. According to the OIG, the advisory opinion – issued in 2006 and modified in 2015 –  was revoked because the charity “failed to comply with certain factual certifications” about independence from donors, potentially steering Medicare beneficiaries toward certain prescription drugs. … Continue reading

FDA embraces medical innovation in 2017

On November 16, 2017, the US Food & Drug Administration (“FDA”) unveiled a comprehensive policy framework – a suite of four guidance documents – to oversee regenerative medicine products. Regenerative medicine is the science of restoring structure and function to damaged or diseased cells, tissues, or organs. The two final guidance documents outline when cell … Continue reading

FDA commissioner looks to curb tactics that restrict drug competition

On November 8, 2017, the U.S. Food and Drug Administration (“FDA”) Commissioner Scott Gottlieb spoke as a keynote speaker at the Federal Trade Commission (“FTC”) workshop, Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics (“Workshop”) and called to “end the shenanigans” that can delay or restrict generic drug competition. Gottlieb discussed his … Continue reading

FDA releases new guidances on increasing generic drug competition

The United States Food and Drug Administration (“FDA”) released four new draft guidances on October 2, 2017 that aim to reduce the barriers for certain generic drugs to enter the market and ultimately, reduce drug prices.  Reducing drug prices was a stated objective of President Trump during his campaign and has also been a topic … Continue reading
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