Tag: FDA enforcement

FDA enforcement

Regulatory/FDA

OPDP Focuses on Misleading Opioid Claims Amid National Crisis

OPDP Focuses on Misleading Opioid Claims Amid National Crisis

Feb. 23, 2021 – Amid a surge in opioid overdose deaths over the past year – due in part to the ongoing COVID-19 pandemic and its corresponding isolation and lack of employment and support services – the FDA’s Office of Prescription Drug Promotion (OPDP) has asserted the agency’s “ongoing commitment to combat inappropriate opioid use.” […]

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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

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

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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Regulatory/FDA

As COVID-19 Pandemic Continues, Promotion of Unapproved “Cures” Abounds

As COVID-19 Pandemic Continues, Promotion of Unapproved “Cures” Abounds

May 4, 2020 – An important part of protecting the public health during the COVID-19 pandemic is making sure that the marketing of treatments or remedies that are not approved by the Food and Drug Administration (FDA) to treat the virus is stopped before consumers waste their money or potentially are harmed by these products. […]

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Regulatory/FDA

FDA Streamlines COVID-19 Product Pathways, Continues to Crack Down on Misleading Claims

FDA Streamlines COVID-19 Product Pathways, Continues to Crack Down on Misleading Claims

April 13, 2020 – The Food and Drug Administration (FDA) is responding to the challenges of COVID-19 in new ways that streamline product review and policy approaches, while also ensuring that entities promoting unapproved products that claim to be effective against the virus do not go unchecked. Last week, the FDA and the Federal Trade […]

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Regulatory/FDA

FDA and FTC: Coronavirus Products Are Fraudulent, Could Delay Treatment

FDA and FTC: Coronavirus Products Are Fraudulent, Could Delay Treatment

March 16, 2020 – Amid rising concerns over “Novel Coronavirus Disease 2019” (COVID-19), the Food and Drug Administration and the Federal Trade Commission took action last week against seven companies for selling fraudulent COVID-19 products. The regulators sent Warning Letters to the companies because these products “are unapproved drugs that pose significant risks to patient […]

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Regulatory/FDA

Press Release Highlighting Omission of Risk Warning Letter Closes OPDP’s Enforcement Year

Press Release Highlighting Omission of Risk Warning Letter Closes OPDP’s Enforcement Year

Dec. 20, 2019 – As 2019 comes to an end, the FDA’s Office of Prescription Drug Promotion issued its third Warning Letter of the year to Alkermes Inc. for a medication-assisted treatment drug print ad for Vivitrol® and followed that up with an unprecedented press release about the enforcement action on Dec. 11. OPDP also […]

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Regulatory/FDA

Promotion of IND for Brain Cancer Treatment Prompts OPDP Enforcement Letter

Promotion of IND for Brain Cancer Treatment Prompts OPDP Enforcement Letter

Dec. 2, 2019 – In its sixth Untitled Letter of 2019, the FDA’s Office of Prescription Drug Promotion (OPDP) cited Nascent Biotech Inc. for promoting an investigational new drug (IND) as a safe and effective treatment for brain cancer on its website. This is the second enforcement letter in 2019 to address issues related to […]

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Regulatory/FDA

FDA Amps Up Foreign Inspections Under Pressure to Bend on Opposition to Drug Importation

FDA Amps Up Foreign Inspections Under Pressure to Bend on Opposition to Drug Importation

Sept. 25, 2019 – The traditional position of FDA’s leadership that the importation of foreign medicines is illegal and may pose safety risks to American patients appears to be in conflict with the Trump administration and other politicians who believe importation to be a key element of lowering prescription drug costs. Now, the agency is […]

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