Category: Regulatory/FDA

Regulatory/FDA

Regulatory/FDA

Despite Strain on Resources During Pandemic, CDER Approves 53 Novel Drugs in 2020

Despite Strain on Resources During Pandemic, CDER Approves 53 Novel Drugs in 2020

Jan. 11, 2021 – When considering all of the COVID-19 challenges the FDA faced in 2020, it is noteworthy that the Center for Drug Evaluation and Research (CDER) approved 53 novel drugs last year, the second highest number of novel drug approvals in the past 10 years. In a forward to CDER’s 2020 report on […]

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Regulatory/FDA

Myers: What the FDA Might Look Like Under Biden

Myers: What the FDA Might Look Like Under Biden

Dec. 21, 2020 – As President-elect Joe Biden takes office in January 2021, understanding what could change and what could remain the same at the FDA is important, according to Nancy Bradish Myers, president and CEO of Catalyst Healthcare Consulting Inc. Myers, who has held key positions at the FDA and in industry, spoke at […]

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Regulatory/FDA

Azurity Email Garners OPDP Enforcement Letter for False/Misleading Claims

Azurity Email Garners OPDP Enforcement Letter for False/Misleading Claims

Dec. 14, 2020 – In a recent Untitled Letter, the FDA’s Office of Prescription Drug Promotion (OPDP) states that claims made by Azurity Pharmaceuticals Inc. in a healthcare professional email for XATMEP® (methotrexate) oral solution indicate that Azurity “appears to be promoting Xatmep without presenting the serious risks of the drug in a truthful and […]

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Regulatory/FDA

HHS OIG Releases Fraud Alert on Speakers Bureaus

HHS OIG Releases Fraud Alert on Speakers Bureaus

Nov. 20, 2020 – In a rare special fraud alert issued Nov. 16, the Department of Health and Human Services Office of Inspector General (OIG) expresses skepticism about the value of company-sponsored speaker bureau events, outlines its concerns about “inherent fraud and abuse risks” associated with these programs, and offers a non-exhaustive list of the […]

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Regulatory/FDA

OPDP Director Tom Abrams Retires, Leaving Mark on Drug Promotion Regulation

OPDP Director Tom Abrams Retires, Leaving Mark on Drug Promotion Regulation

Nov. 2, 2020 – After 27 years with the Office of Prescription Drug Promotion (OPDP) – formerly called the Division of Drug Marketing, Advertising, and Communication (DDMAC) – OPDP Director Tom Abrams retired from the agency on Oct. 23 as the primary force behind today’s regulation of prescription drug advertising and promotion. Abrams’ leadership shaped […]

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Regulatory/FDA

Bad Ad Complaints Yield Two OPDP Warning Letters, One on COVID Email Claims

Bad Ad Complaints Yield Two OPDP Warning Letters, One on COVID Email Claims

Oct. 12, 2020 – The FDA’s Office of Prescription Drug Promotion (OPDP) enforcement efforts are picking up steam following a slow start – just one enforcement letter issued between January 2020 and July 2020 – with two recent Warning Letters resulting from complaints through the agency’s Bad Ad Program. In a Sept. 22 Warning Letter […]

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Regulatory/FDA

Addyi Radio Ad Garners OPDP Warning Letter for Omission of Risks

Addyi Radio Ad Garners OPDP Warning Letter for Omission of Risks

Sept. 21, 2020 – A radio ad that promotes the benefits of a product but omits all of the contraindications associated with its use creates “a misleading impression about the drug’s safety,” according to an FDA Office of Prescription Drug Promotion (OPDP) Warning Letter issued recently to Sprout Pharmaceuticals Inc. for ADDYI®, a female libido […]

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Regulatory/FDA

Despite COVID-19 Distractions, FDA Approving Drugs at Fast Pace

Despite COVID-19 Distractions, FDA Approving Drugs at Fast Pace

Aug. 20, 2020 – The Food and Drug Administration’s (FDA’s) ability to approve new drugs while juggling new responsibilities during the COVID-19 pandemic appears to be exceeding expectations, with the agency approving 36 novel drugs to date in 2020, an increase from the 24 new molecular entities (NMEs) approved by this date in 2019 (with […]

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Regulatory/FDA

Hahn: Lessons Learned in Pandemic May Lead to Permanent FDA Changes

Hahn: Lessons Learned in Pandemic May Lead to Permanent FDA Changes

June 9, 2020 – Speaking at a June 1 presentation to the Alliance for a Stronger FDA, FDA Commissioner Dr. Stephen Hahn said that despite criticisms of its performance during the COVID-19 pandemic, FDA’s “decisions [will] always be rooted in science,” and that lessons learned during the pandemic “will lead to permanent improvements at the […]

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Regulatory/FDA

By One Measure, 2020 OPDP Enforcement Is Off to Slow Start

By One Measure, 2020 OPDP Enforcement Is Off to Slow Start

May 26, 2020 – Since 2015, the FDA’s Office of Prescription Drug Promotion (OPDP) has issued a yearly high of 11 enforcement letters (2016) and a low of five enforcement letters (2017), and so far in 2020, OPDP has issued just one enforcement letter. The three Warning Letters and seven Untitled Letters issued by OPDP […]

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