Your Prescription Isn’t Ready Yet

With new drug approvals at a six-year low, life-saving treatments may have to wait

by Carleen Wild | Updated 04 Jan 2017 at 8:22 AM

People faced with a life-threatening illness are often told to “have hope.” They’re told the next treatment could soon be available to improve, heal, or even save their lives.

They’re told that unprecedented investments are being made into medical research to make these things happen.

When faced with a life-threatening illness, people want to believe.

So when news comes that drug approval is at its lowest in six years, it can be disheartening — because it most likely means that next new treatment isn't coming fast enough to make a difference in one's life, or that of someone they love.

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Only 22 new medicines were approved for sale by the U.S. Food and Drug Administration in 2016, Reuters Health reported on Tuesday — that is the lowest number since 2010 and sharply down from 2015's tally of 45.

Overseas, the European Medicines Agency recommended 81 new prescription products against a 2015 total of 93. Generic drugs are included in that list.

"Pharmacological development takes a really long time and is one of the most complicated approval and development processes in the world," said a former FDA expert.

The FDA's director of the office of new drugs, John Jenkins, said a number of factors caused the decline in approvals. Among them, there were fewer applications overall last year — and of those filed for approval, more were rejected or delayed than in years past.

"The FDA can only approve complete and full applications that are sent to them," said Dr. David Gortler, professor of pharmacology and a former FDA senior medical officer now with FormerFDA.com. "When the FDA rejects a new drug for approval, it does not represent a failure on the part of the FDA. Years with greater numbers of applications don't mean that the FDA is doing better or worse."

The pharmaceutical industry is also struggling with the cost of getting a drug to market — and what appears a sinking financial return once a drug is launched. the Tufts Center for the Study of Drug Development estimates that it costs at least $2.6 billion to get a drug through all three clinical trial phases and approval. The average return on research and development at the top 12 pharmaceutical companies, meanwhile, fell to 3.7 percent in 2016 from a high of 10.1 percent in 2010, according to the consultancy firm Deloitte.

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All of this comes at a time when research is getting more specialized and expensive — and individuals, insurers, and governments are increasingly critical of the exorbitant costs.

The last drug to win FDA approval in 2016, according to Reuters, was Spinraza. The medicine, from Biogen and Ionis Pharmaceuticals, is the first to treat patients with spinal muscular atrophy, a rare and often fatal genetic disease. It costs $125,000 per dose.

That price, implying a total cost of $625,000 to $750,000 for patients in the first year and $375,000 in subsequent years, is likely to invite "a storm of criticism, up to and including presidential tweets," according to Leerink analysts, Reuters reported.

"The drug approval process is definitely inefficient," Gortler told LifeZette. "But it's the best time-tested method we have for evaluation safety and efficacy to date. As inefficient as it is, it would take a compelling argument or methodology from someone to remove or reduce any of the Phase 1-3 clinical evaluation steps."

There are very obvious critics of the drug approval process and of pharmaceutical companies who appear only out for themselves — that this is more about money than new life-saving medicines. People are especially leery, given there are thousands of generic drug applications awaiting approval and, on average, it takes the FDA upward of 47 months to get to them, according to the Generic Pharmaceutical Association.

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Gortler, after 20 years of working as a medical scientist in drug development, said he doesn't believe that's the case.

"Pharmacological development takes a really long time and is one of the most complicated approval and development processes in the world. If there was some cure-all, as human beings we would be ethically and financially motivated to share it," said Gortler.

  1. drug development
  2. fda
  3. health care
  4. pharmaceuticals
  5. prescription drugs
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