Statement from FDA Commissioner Scott Gottlieb, M.D., on the importance of the Drug Quality and Security Act and overseeing the safety of compounded drugs

FDAIn late 2012, the United States faced the most serious outbreak associated with contaminated compounded drugs in recent history, involving hundreds of people, in many states, who developed fungal infections related to a compounded product. It was an incident that resulted in dozens of deaths.

The fungal meningitis outbreak underscores the need for robust oversight over human drug compounding, the importance of dispensing prescription drugs pursuant to valid prescriptions and the need for strong coordination with state regulatory partners to protect public health.

Since that outbreak and the subsequent enactment of the Drug Quality and Security Act (DQSA) on Nov. 27, 2013, the FDA has devoted significant resources to oversee compounding and implement the compounding provisions of the law. As of June 1, 2017, the FDA has conducted more than 400 inspections, including 109 inspections of outsourcing facilities; issued more than 150 warning letters advising compounders of significant violations of federal law; issued more than 50 letters referring inspectional findings to state regulatory agencies; overseen over 125 recalls involving compounded drugs; and worked with the Department of Justice on a number of civil and criminal enforcement actions.

As part of the implementation of DQSA, we have also issued 21 draft guidances, ten final guidances, three proposed rules, a final rule, and a draft memorandum of understanding. We have taken a risk-based approach to all of these efforts, in order to make sure that we are maximizing the public health purpose of these new provisions relative to the resources we use to achieve them, and any obligations that these new requirements place on market participants. These foundational regulations and guidance documents provide predictability and transparency to compounders, providers, and other enterprises; and inform them of how to comply with the law’s provisions in the most efficient manner.

These efforts are part of our commitment to doing all we can to protect the public from poorly compounded drugs. We will continue to actively oversee drug compounders and, when appropriate, initiate regulatory action as it fulfills the FDA public health mission on behalf of patients.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Most Popular Now

Positive Phase 1 data from mRNA-based individualiz…

BioNTech SE (Nasdaq: BNTX, "BioNTech") announced initial data from an ongoing investigator-initiated first-in-human Phase 1 study evaluating the safety and tolerability o...

FDA approves RIABNI™ (rituximab-arrx), a biosimila…

Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved RIABNI™ (rituximab-arrx), a biosimilar to Rituxan®, in combination with ...

Pfizer to invest $120 million to produce COVID-19 …

Pfizer Inc. (NYSE: PFE) announced today that it will further strengthen its commitment to United States manufacturing with a $120 million investment at its Kalamazoo, Mic...

Proteomic study of 2,002 tumors identifies 11 pan-…

A new study that analyzed protein levels in 2,002 primary tumors from 14 tissue-based cancer types identified 11 distinct molecular subtypes, providing systematic knowled...

A new technology offers treatment for HIV infectio…

A new study from Tel Aviv University offers a new and unique treatment for AIDS which may be developed into a vaccine or a one time treatment for patients with HIV. The s...

Sanoff offers perspective on a promising rectal ca…

UNC Lineberger Comprehensive Cancer Center's Hanna K. Sanoff, MD, MPH, is the author of a viewpoint in the New England Journal of Medicine that provides a perspective on ...

Boehringer Ingelheim signs option to acquire Truti…

Boehringer Ingelheim announced the signing of an option to acquire Trutino Biosciences Inc. (the "Transaction"), a San Diego-based biotech company. Trutino Biosciences...

Broadly neutralizing antibodies could provide immu…

Two broadly neutralizing antibodies show great promise to provide long-acting immunity against COVID-19 in immunocompromised populations according to a paper published Ju...

Novel drug combo activates natural killer cell imm…

Most skin cancer drugs that activate the immune system work by triggering immune cells, called T cells, to attack tumors, but when T cells are activated for too long, the...

Novartis announces Nature Medicine publication of …

Novartis announced that Nature Medicine published final results from both the two- and three-copy cohorts of the completed Phase 3 SPR1NT trial as separate companion manu...

COVID-19 rebound after taking Paxlovid likely due …

Paxlovid is the leading oral medication for preventing severe cases of COVID-19 in high-risk individuals. However, symptoms returned in some patients after treatment was ...

Biomarkers found that could be drug targets agains…

Biomarkers that could be targets for novel drugs to treat glioblastoma brain tumors have been identified by investigators at Georgetown Lombardi Comprehensive Cancer Cent...