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Have FDA Actions to Ease Generic Drug Shortages Taken Effect Yet?


Drug shortages are an increasing problem—witness the news this week that the chemotherapy drug vincristine, a mainstay in fighting pediatric cancer, is in such short supply that doctors may be forced to start rationing, according to published reports. On Wednesday, the FDA said fiscal year 2018 saw a record number of generic drug approvals.

Fiscal year 2018 saw a record number of generic drug approvals, the FDA said, amid continuing concerns about shortages of critical drugs and rising costs.

Drug shortages are an increasing problem—witness the news this week that the chemotherapy drug vincristine, a mainstay in fighting pediatric cancer, is in such short supply that doctors may be forced to start rationing, according to published reports.

Such care interruptions have become more common, due to shortages of older, off-patent drugs and insufficient generic competition. Besides creating patient care issues, the shortages also limit potential cost savings.

In the statement released Wednesday, the FDA notes that generic drugs account for about 90% of all prescription drug purchases; last year, competition from generic drugs saved the about $293 billion.

In 2017, the FDA released the Drug Competition Action Plan, and implemented certain aspects of the Generic Drug User Fee Amendments included in the FDA Reauthorization Act, to promote competition among drugs no longer protected by market exclusivity and expedite application review of generics.

In the statement Wednesday, Acting Commissioner Ned Sharpless, MD, said the FDA's actions are working, creating "a thriving generic drug program that continues to impress me." He said fiscal year 2019 figures overall show a total of 1171 generic drug approvals (935 full approvals and 236 tentative approvals), compared with last year's previous record of 971.

Of the 1171, 125 applications were for first generics of medicines that had no generic competition, including an emergency opioid overdose treatment and drugs to treat pulmonary arterial hypertension, breast cancer, seizures, depression and various infections. He also said the FDA is approving increasing numbers of complex generic drugs, which are harder to copy and traditionally have lacked competition.

Recently, researchers attempted to characterize generic drug approvals in the wake of generic drug shortages, including ones with limited competition. The objective of their study was to characterize those recent generic drug approvals, particularly for drugs with limited competition or had previously been in shortage, and to see if there has been any noticeable impact from the FDA’s efforts. But their results indicate it is too early to tell.

Writing in JAMA Network Open last week, researchers describe using the Drugs@FDA database to identify all abbreviated new drug applications (ANDAs) approved by FDA from July 1, 2016, to December 31, 2018.

FDA policy defines competition as the presence of 2 or fewer versus 3 or more existing manufacturers of a generic drug at the time of approval. A prior drug shortage is defined as any drug shortage lasting 1 month or longer for the same active ingredient and dosage from within 5 years prior to approval.

The authors excluded tentative approvals, biologic treatments, over-the-counter products, and discontinued ANDAs. They included the corresponding brand-name drug’s initial approval year, priority review status, Orphan Drug Act designation, World Health Organization essential medicine status, therapeutic area based on World Health Organization Anatomical Therapeutic Chemical code classification, and drug complexity.

Between July 2016 to December 2018, the FDA approved 1832 ANDAs covering 533 different active ingredients.

In the third quarter of 2016, there were 133 ANDA approvals; after increasing for a time, they fell to 102 ANDA approvals in the first quarter of 2018. They rose to 262 ANDA approvals in the fourth quarter of 2018.

The corresponding brand-name products for these generic drugs were most commonly approved from 1995 to 2004 (761 drugs [41.5%]). By category, they treated neurologic (426 drugs [23.3%]), cardiovascular (256 drugs [14.0%]), or infectious (229 drugs [12.5%]) diseases.

Of the 741 brand-name drugs:

  • 456 (24.9%) had received priority review
  • 244 (13.3%) were designated as orphan drugs
  • 364 (19.9%) were listed as World Health Organization essential medicines
  • 351 (19.2%) were determined to be complex drugs

Among the 1832 ANDA approvals, 374 (20.4%) were in limited competition at the time of approval, ranging from 27 drugs (14.2%) in the third quarter of 2017 to 39 drugs (29.3%) in the third quarter of 2016.

In addition, 717 drugs (39.1%) had experienced a shortage in the previous 5 years, ranging from 45 drugs (28.1%) in the fourth quarter of 2016 to 107 drugs (46.1%) a year later.

Even though the total number of generic drug applications approved by the FDA rose slightly, the proportion of approvals for drugs that faced limited competition or had previously been in shortage remained steady, the authors write.

There were some limits to their work, the authors note; they only examined FDA approvals, not whether companies brought their approved drug to market after approval. In addition, other studies have defined shortages differently.

Although the results suggest that the result of the FDA’s actions to expand approvals for generic drugs at risk for price hikes and shortages are not yet evident, the authors note that ANDAs take time for the manufacturer to prepare and then another 6 to 12 months for regulatory review.

Despite that possible explanation for the lack of a sustained effect of the FDA’s actions, continued focus on this issue is still needed, the authors write.


Jiao K, Gupta R, Fox E, Kesselheim A, Ross JS. Characteristics of recent generic drug approvals by the US Food and Drug Administration [published online October 11, 2019]. JAMA Netw Open. doi:10.1001/jamanetworkopen.2019.13029.

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