The federal government and pharmaceutical giant Pfizer announced that they will allow their popular narcolepsy drug to be made cheaper and sold more widely in poor countries, following a recent request from an advocacy group.
The Narcolepsy Foundation asked the drug company to alter its drug to prevent repeats of the antipsychotic drug known as Depakote. At a briefing in Washington, supporters of the drug company indicated that the government would be forgiving “for every single dosage or dose with the exception of a box-out exception.”
Supporters are claiming this could save African countries up to 30 billion U.S. dollars over 10 years as cheap drugs could be sold abroad instead of expensive ones.
Depakote is available in 20 countries in the world, including Mexico, Central America, South America, and Africa. Officials claim Pfizer will sell the drug in Tanzania at 55 cents a pill.
Pfizer reacted to the news of the discount by claiming that many people suffer severe side effects from Subsys but that they “will continue to provide support, including follow-up care and a range of services at reduced rates, to those patients currently on the drug.”
(Continued in 2nd par)
“We must all do more to address the devastating opioid epidemic,” Commissioner Scott Gottlieb of the Food and Drug Administration said in a statement. “These actions are an important step toward improving access to these critically important and life-saving medications, without exposing Americans to unnecessary risk.”
The NFA argues that having one powerful drug to treat as many as 25 major seizures is insufficient. The first comparison of the drug was made in 2015 to oxycodone, the fentanyl of painkillers.
The National Health Law Program, a Washington, D.C.-based nonprofit, argued on their website that the drug is too heavily prescribed, causing severe side effects. The drug has been shown to cause seizures, high levels of drowsiness, nightmares, motor impairment, and urinary retention, and side effects can linger for decades.
Pfizer has argued that it takes twice as long to prescribe the drug for 30 days in that clinic setting. Officials say it can take up to 18 months for each patient to get the drug to limit withdrawal. The drug is also an expensive product for patients, going for a little over $1,000 a month.
The group also noted that opioid prescribing rates in the United States have nearly doubled from 2005 to 2015. Nearly half of all Americans will have had some form of opioid addiction at some point in their lives.
By pushing drug addiction into poor nations, group says that the U.S. is not only enabling people to lose their liberty to steal prescription pills, but it is also exporting what it considers to be a dangerous drug to countries that need help fighting their own opioid problems.
“Pfizer’s market-to-market strategy is a classic opioid market share strategy—selling high-volume pills in markets where potential users (and would-be addicts) are lower-income or near-poor,” the NHEFP said.
“The average American family can’t afford to buy drugs—now foreign countries can. China, India, Brazil, Nepal, Brazil, Columbia, and more will each see drug trafficking skyrocket; once they have the drug, they can call the shots. It will set off an unintended chain reaction that will need to be stopped.”
The NHEFP worked with the Associated Press and ProPublica to get a sneak peek of Pfizer’s 10-year plans for the drug. It would require the World Health Organization and other global organizations to grant the drug their approvals for its use.
Last year, the FDA granted Indian pharmacists the right to give Narcan, Narboela, and other overdose reversal drugs to inpatients seeking treatment. Many patients began using the drug, which is quick and has a low burn rate, on themselves.
The drug is meant to be self-administered over-the-counter. Supporters also note that although the generic brand names of Depakote mimic “brand name” drugs on the market, the specific materials used in those drugs are a risk for unintentional overdoses, because these medications are less sterile.
This makes generic versions of drugs that are safer less expensive than the more expensive ones.
Source: The NHTSA and the Associated Press