US launches Civica Rx to tackle high prices, as FDA gets set to approve record ANDAs

By PharmaCompass

2018-09-13

Impressions: 186 Article

Shortages of lifesaving drugs is a key worry for several countries across the world. In the US, drug shortages have been widespread for more than a decade.

Last week, several major hospital groups in the US got together to launch their own generic drug company — christened Civica Rx — to tackle chronic drug shortages and high prices. The initiative was announced in January 2018. Since then, more than 120 health organizations representing about a third of America’s hospitals have contacted Civica Rx and have expressed a commitment or interest in participating with the new company.

This not-for-profit generic drug company will help patients by addressing drug shortages and high prices of lifesaving medications. Civica Rx will be headquartered in Utah.

Civica Rx plans to start with 14 widely used hospital drugs that have been in short supply for a long time. Besides creating a reliable supply for its 500 hospitals, Civica aims to reduce drug prices by about 20 percent.

On its part, the FDA is announcing a public meeting entitled ‘Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions’. The purpose of the meeting is to give stakeholders, including healthcare providers, patients, manufacturers, wholesalers, pharmacists, pharmacy benefit managers, veterinarians, public and private insurers, academic researchers, and the public, the opportunity to provide input on the underlying systemic causes of drug shortages, and make recommendations for actions to prevent or mitigate drug shortages. The public meeting will be held on November 27, 2018.

Meanwhile, in Canada, about 1,200 drug products go into short supply every year. At any given moment, there are at least 700 to 1,000 drug shortages.

Last week, 25 new drugs were listed on Canada’s drug shortage website. These include treatments for migraines, Parkinson’s disease, schizophrenia, depression, hepatitis B, genital herpes, hypertension, and even generic Viagra.

Last week, Canada’s health minister signed an order permitting US supplies of another brand of epinephrine auto-injectors to be sold in Canada to help solve the EpiPen shortage.

This is happening at a time when the FDA is on track to approve a record number of abbreviated new drug applications (ANDAs) in FY 2018.

The FDA has approved 666 ANDAs in the fiscal year through July and has tentatively approved another 162 ANDAs. With an average of 67 ANDA approvals and 16 tentative approvals each month this year, FDA will likely top its record-setting FY 2017 performance.

In FY 2017, FDA approved or tentatively approved 937 ANDAs, breaking its previous record of 835 in 2016.

As part of FDA’s efforts to address growing prescription drug spending, Commissioner Scott Gottlieb has also made the approval of generic drugs, especially first generics and generics to drugs with little competition, a priority.

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