"Average 12 years and over $350 million to get a new drug from the laboratory onto the pharmacy shelf."
The PTSD cave-in by HHS-NIDA is arguably a political bone thrown a) to veterans for face-saving and b) to the administration's political base for showboating. HHS (in the name of the American people) already holds a 2003 US patent citing cannabinoids as neuroprotectants,. As is their modus operandi, this latest episode is more political grandstanding and theater than anything else.
FDA approval is no cake walk. Big Pharma spends an average $5.8 billion development on each of their new drugs that eventually reach market (when the costs of 95% of their failures are included). BP's influence over the FDA is no myth. Why would FDA be inclined to move faster than their usual snail's pace in the case of cannabinoids which, as a class, are a dire threat to Big Pharma hegemony? FDA might even proceed more slowly, if that's possible, all the while appeasing their critics by cooing over their greenlighting of this clinical study. Meanwhile, veterans will seek relief from PTSD in MMJ-legal states and other venues.
"It takes on average 12 years and over US$350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes around three and a half years of laboratory testing, before an application is made to the U.S. Food and Drug Administration (FDA) to begin testing the drug in humans. Only one in 1000 of the compounds that enter laboratory testing will ever make it to human testing.
If the FDA gives the green light, the "investigative" drug will then enter three phases of clinical trials:
Phase 1 uses 20-80 healthy volunteers to establish a drug's safety and profile. (about 1 year)
Phase 2 employs 100-300 patient volunteers to assess the drug's effectiveness. (about 2 years)
Phase 3 involves 1000-3000 patients in clinics and hospitals who are monitored carefully to determine effectiveness and identify adverse reactions. (about 3 years)
The company then submits an application (usually about 100,000 pages) to the FDA for approval, a process that can take up to two and a half years. After final approval, the drug becomes available for physicians to prescribe. At this stage, the drug company will continue to report cases of adverse reactions and other clinical data to the FDA.
The research-based pharmaceutical industry currently invests some US$12.6 billion a year in new drug development. Historically, the drug development figure doubles every five years."
http://www.drugs.com/fda-approval-process.htm
"The true amount that companies spend per drug approved is almost certainly even larger today. My Forbes colleague Matthew Herper recently totaled R&D spending from the 12 leading pharmaceutical companies from 1997 to 2011, and found that they had spent $802 billion to gain approval for just 139 drugs: a staggering $5.8 billion per drug."
Manhattan Institute Project FDA Report No. 5. "Stifling New Cures: The True Cost of Lengthy Clinical Trials," by Avik Roy.
The PTSD cave-in by HHS-NIDA is arguably a political bone thrown a) to veterans for face-saving and b) to the administration's political base for showboating. HHS (in the name of the American people) already holds a 2003 US patent citing cannabinoids as neuroprotectants,. As is their modus operandi, this latest episode is more political grandstanding and theater than anything else.
FDA approval is no cake walk. Big Pharma spends an average $5.8 billion development on each of their new drugs that eventually reach market (when the costs of 95% of their failures are included). BP's influence over the FDA is no myth. Why would FDA be inclined to move faster than their usual snail's pace in the case of cannabinoids which, as a class, are a dire threat to Big Pharma hegemony? FDA might even proceed more slowly, if that's possible, all the while appeasing their critics by cooing over their greenlighting of this clinical study. Meanwhile, veterans will seek relief from PTSD in MMJ-legal states and other venues.
"It takes on average 12 years and over US$350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes around three and a half years of laboratory testing, before an application is made to the U.S. Food and Drug Administration (FDA) to begin testing the drug in humans. Only one in 1000 of the compounds that enter laboratory testing will ever make it to human testing.
If the FDA gives the green light, the "investigative" drug will then enter three phases of clinical trials:
Phase 1 uses 20-80 healthy volunteers to establish a drug's safety and profile. (about 1 year)
Phase 2 employs 100-300 patient volunteers to assess the drug's effectiveness. (about 2 years)
Phase 3 involves 1000-3000 patients in clinics and hospitals who are monitored carefully to determine effectiveness and identify adverse reactions. (about 3 years)
The company then submits an application (usually about 100,000 pages) to the FDA for approval, a process that can take up to two and a half years. After final approval, the drug becomes available for physicians to prescribe. At this stage, the drug company will continue to report cases of adverse reactions and other clinical data to the FDA.
The research-based pharmaceutical industry currently invests some US$12.6 billion a year in new drug development. Historically, the drug development figure doubles every five years."
http://www.drugs.com/fda-approval-process.htm
"The true amount that companies spend per drug approved is almost certainly even larger today. My Forbes colleague Matthew Herper recently totaled R&D spending from the 12 leading pharmaceutical companies from 1997 to 2011, and found that they had spent $802 billion to gain approval for just 139 drugs: a staggering $5.8 billion per drug."
Manhattan Institute Project FDA Report No. 5. "Stifling New Cures: The True Cost of Lengthy Clinical Trials," by Avik Roy.
