Is the FDA's Speedy Approval of New Drugs Putting Us at Risk?

The FDA's priority review process is putting new drugs on the market in just six months rather than the usual ten months.

Is the FDA's Speedy Approval of New Drugs Putting Us at Risk?

A December 6, 2019 story by Bloomberg reported that the U.S. Food and Drug Administration (FDA) is approving new drugs at an unprecedented rate.

In October 2019, Trikafta, a drug from Vertex Pharmaceuticals Inc. used to treat cystic fibrosis, was approved five months early. Vertex's investors called it an early Christmas gift from the FDA.


On November 25, 2019, the FDA approved Global Blood Therapeutics Inc.'s new sickle cell drug, Oxbryta, almost three months ahead of its scheduled approval date, which is known as the Prescription Drug User Fee Act (PDUFA) date. PDUFA was passed in 1992, and it allows the FDA to collect fees from drug manufacturers to fund the new drug approval process.

Another sickle cell drug, Adakveo, from Novartis AG, was approved in November 2019, 62 days ahead of its scheduled approval date. A drug to treat mantle cell lymphoma, BeiGene Ltd.'s Brukinsa, was approved three months ahead of its PDUFA date.

What's driving this change?

Normally, it takes the FDA ten months to approve a new drug, however, for drugs that treat conditions that have few therapies, or for drugs that show exceptional promise, the FDA offers a priority review that takes only six months.

1957 DES ad
1957 DES ad, Source: Marcia Wendorf

That priority review was given to three-fourths of the record number of drugs that were approved in 2018, 59. During one thirty day period in 2019, from mid-October to mid-November, the FDA approved five medicines, the quickest taking only eight weeks.

Pharmaceutical manufacturers explain this landslide of new drugs by touting breakthroughs in biotechnology and genetics and say that their scientists are providing the FDA with better data.

2002 Vioxx ad
2002 Vioxx ad, Source: Marcia Wendorf

The Bloomberg article quoted the director of the FDA Center for Drug Evaluation and Research, Janet Woodcock, as saying, "If there are people out there with no options and they have terrible diseases, we are going to get those drugs to them as fast as feasible."


While that's great for sufferers, it's also great for the pharmaceutical manufacturers, and those who invest in them, but is the expedited process putting the public's health at risk?

A risk to our health?

According to a recent study, drugs that went through the expedited approval process rather than the regular process were 48% more likely to get either a black-box warning or to receive contraindications that restrict the drug's use.

FDA black-box warning
FDA black-box warning, Source: Marcia Wendorf

Black box warnings are the FDA's strictest labeling requirement. First implemented in 1979, black-box warnings highlight serious and sometimes life-threatening adverse drug reactions.

A 2017 study reported that 71 of the 222 drugs approved by the FDA between 2000 and 2010 were withdrawn, required a black-box warning, or received a safety warning.

More worrying still, the study found that the FDA approved new drugs faster than it's European counterpart, the European Medicines Agency (EMA).


Drugs that have been pulled from the market due to safety concerns include:

DrugUseYearsManufacturerReason for the Recall
Accutane (Isotretonoin)Acne1982 - 2009Hoffman-La RocheIn pregnant women, an increased risk of birth defects, miscarriages, and premature births; inflammatory bowel disease, suicide
Baycol (Cerivastatin)Cholesterol reduction1998 - 2001Bayer A.G.Rhabdomyolysis, a breakdown of muscle which leads to kidney failure; 52 deaths worldwide, 385 hospitalized
Bextra (Valdecoxib)Pain relief2001 - 2005G.D. Searle & Co.Cardiovascular events such as heart attack and stroke, toxic epidermal necrolysis, gastrointestinal bleeding
Darvon and Darvocet (Propoxyphene)Opiod pain reliever1955 - 2010XanodyneToxicity to the heart resulting in 2,110 deaths between 1981 and 1999
DES (Diethylstibestrol)Prevent miscarriage and premature labor1940 - 1971Grant Chemical Co.In the children of mothers who took the drug, cancer of the cervix and vagina, birth defects, increased risk of breast cancer, early menopause, testicular abnormalities; tests are currently being carried out on the grandchildren of women who took the drug
Meridia (Sibutramine)Appetite suppressant1997 - 2010Knoll PharmaceuticalsIncreased heart attack and stroke risk
Pondimin (Fenfluramine)Appetite suppressant1973 - 1997Wyeth-AyerstBetter known as "Fen-Phen" when used with Phentermine, 30% using the drug had abnormal echocardiograms, cases of heart valve disease
Propulsid (Cisapride)Heartburn and gastroesophageal reflux disease (GERD)1993 - 2000Janssen Pharmaceutica270 cases of serious cardiac arrhythmias, 70 deaths
Raptiva (Efalizumab)Psoriasis2003 - 2009GenentechProgressive multifocal leukoencephalopathy, a fatal disease caused by damage to the white matter in of the brain
Rezulin (Troglitazone)Antidiabetic and anti-inflammatory1997 - 2000Parke-Davis/Warner Lambert (now Pfizer)90 liver failures, 63 deaths, 35,000 personal injury lawsuits
Vioxx (Rofecoxib)Pain relief1999 - 2004MerckPrescribed to more than 20 million people, it caused an increased risk of heart attack and stroke, between 1999 and 2003, 27,785 heart attacks were reported.
Zelnorm (Tegaserod maleate)Irritable bowel syndrome and constipation2002 - 2007NovartisHigher chance of heart attack and stroke, unstable angina


Zelnorm ad
Zelnorm ad, Source: Marcia Wendorf

A 2017 NPR article quoted Dr. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness as saying, "All too often, patients and clinicians mistakenly view FDA approval as [an] indication that a product is fully safe and effective. Nothing could be further from the truth. We learn tremendous amounts about a product only once it's on the market and only after use among a broad population."

The public's only response to that is "caveat emptor", or let the buyer beware.

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