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OPDP Issues Two Enforcement Letters: Continuing Focus on Promotion of Drugs with Serious Risks & Drugs for Diseases With...

On September 13, 2019, FDA’s Office of Prescription Drug Promotion (OPDP) issued a Warning Letter stating that a professional email made false or misleading claims and representations about the risks and effectiveness...more

FDA Says a Medical Device Sterilizer’s Promotion Is Too Hot to Touch

The Food and Drug Administration, channeling Kool & The Gang’s 1979 hit, “Too Hot,” issued a Warning Letter to a medical device company that marketed a sealed sterilization container for unlawful promotion. ...more

FDA Has Not Gone Away When It Comes to Unlawful Medical Device Promotion: Companies Receive Warning Letters for Violative...

In April 2019, the Food and Drug Administration issued two Warning Letters to medical device manufacturers, reminding industry that the agency will take enforcement action against unlawful promotion when it sees fit. One...more

AGG Food & Drug Newsletter - August 2018

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

It Starts and Stops at the Top: FDA Issues Warning Letters for Lack of Corporate Oversight

The Food and Drug Administration issued two Warning Letters recently to pharmaceutical manufacturers where lack of corporate oversight was an issue. These Warning Letters reaffirm that senior management cannot delegate or...more

Who Me? Yes, You. Couldn’t Be. Then Who?: FDA Reinforces That Contract Manufacturers Can’t Delegate Away Regulatory...

When my children were younger, we played a little game about “who took the cookie from the cookie jar” – Who me? Yes, you. Couldn’t be. Then who? We’d turn to another family member and start the game all over again. ...more

Don’t You Forget About Me: FDA Kicks off 2018 with Letters on Promotional Activities

FDA’s Office of Prescription Drug Promotion (OPDP) issued only five letters in 2017 (compared to eleven in 2016 and nine in 2015). This relatively slow year left some prescription drug manufacturers wondering if, to quote the...more

Get by with a Little Help from My Friends (Maybe Not): FDA Reiterates Reliance on Others Doesn’t Ensure Regulatory Compliance

Here we go again. The Food and Drug Administration issued a Warning Letter on December 13, 2017, to a Korean pharmaceutical company for non-compliance with current Good Manufacturing Practice requirements. What caught our eye...more

AGG Food & Drug Newsletter - October 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

You Can’t Change That: FDA Reiterates Risk of Delegating Responsibility in Quality Agreements

In the span of three weeks, the Food and Drug Administration issued Warning Letters to two dietary supplement companies, in part, for relying, to their detriment, on quality agreements. We discussed another similar Warning...more

I Won’t Back Down: Another Company Refuses to Permit FDA to Inspect

Not long ago, we wrote about a company that refused to permit an FDA investigator to conduct an inspection. Well, here we go again. Apparently a fan of the late, great Tom Petty, the company told the agency, “I won’t back...more

AGG Food & Drug Newsletter - September 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

You Can’t Pass the Regulatory Compliance Buck with a Quality Agreement; FDA Reiterates the Point in a Recent Warning Letter

Companies can’t sign quality agreements and then say “we’re done.” This message was brought home with a recent Warning Letter issued by the Food and Drug Administration to a pharmaceutical company for violating current good...more

The Devil is Really in the Details: FDA Issues Warning Letter to a Drug Company for Disseminating False and Misleading Information

They’re back. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP), which has been relatively quiet on the enforcement front, issued a Warning Letter to a pharmaceutical company for distributing...more

AGG Food & Drug Newsletter - June 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Spelling Counts (Among Other Things): FDA Issues Warning Letters for Mistakes in Drug Listing

Recently, the Food and Drug Administration issued two Warning Letters to pharmaceutical companies for failing to fulfill product listing obligations for what appear to be oversights. In the first letter issued at the end of...more

Things That Make You Go Hmmm, Part II: Drug Company Plays Games With FDA To Delay Facility Inspection

More than ten years ago, I wrote an article about a company action that invoked a memory of my then-3-year old son’s playful “The Thinker” pose. (I continue to have this picture hanging in my office now.) He would frequently...more

FDA Is Cold As Ice As It Steps Up Foreign Inspection Enforcement

So far, in 2017, the Food and Drug Administration’s Office of Manufacturing Quality in the Center for Drug Evaluation and Research has released fourteen Warning Letters. Of these, 100% involved manufacturing facilities...more

Anyone Can Enter Into a Quality Agreement, It's the Hold: FDA Issues a Warning Letter Referencing Lack of Quality Oversight

Many of us remember the classic comedy bit on the Seinfeld television show where Jerry was unable to secure the rental car for which he had made a reservation. He tells the agent: See, you know how to ‘take’ the...more

Happy Holidays from FDA: The Agency Issues Four Enforcement Letters for Unlawful Promotion

The Food and Drug Administration recently issued holiday gifts, in the form of enforcement letters, to four pharmaceutical companies. The letters are reminders that FDA is not in a partying mood when it comes to unlawful...more

AGG Food & Drug Newsletter - October 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

What a Difference a Claim Can Make: FDA Issues a Warning Letter for Unlawful Medical Device Promotion

Much has been written, including by us, about the Food and Drug Administration’s enforcement approach (or lack thereof) concerning off-label promotion. However, FDA has not curled itself up into a ball, abdicating its...more

Don’t Come Around Here No More: A Drug Company Receives a Warning Letter for Limiting Inspection

In the “what were they thinking department,” a drug company located outside of the United States recently received a Warning Letter for limiting and refusing an FDA inspection. In addition, the agency placed the company on an...more

You Wear It Well (or Do You?): FDA Objects To These Skincare Companies’ Unapproved New Drug Claims

In the 1972 hit, “You Wear it Well,” Rod Stewart sang about a woman and offered the classic line, “Madame Onassis got nothing on you.” The tune came to mind when reading four Warning Letters issued by the Food and Drug...more

The First Cut is the Deepest: FDA Issues a Warning Letter to a Skincare Company for Marketing Unapproved New Drugs

The Food and Drug Administration recently issued a Warning Letter to a skincare company for promoting and selling unapproved new drugs. While the letter itself is not unusual in content, the enforcement action continues a...more

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