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Trump Administration declares opioid epidemic a national emergency
On Thursday, President Donald Trump declared the opioid epidemic a national emergency, accepting a recommendation from a national commission that he appointed. The designation could unlock more support and resources to combat the drug overdose epidemic and could allow states and cities that are hardest hit to receive federal disaster relief funds and other types of urgent aid – including additional access to naloxone, the overdose reversal drug, and various forms of treatment. It also gives the government more flexibility in waiving rules and restrictions to expedite action. The 21st Century Cures Act, which Congress approved last year, is already sending states $1 billion over two years for opioid addiction treatment and prevention, but experts say it is far short of what is needed.
Drug cost conversation continues
United Therapeutics sues government over exclusive rights to drug
One of Maryland’s largest drug manufacturers is suing the federal government to prevent competition for a rare disease medication. United Therapeutics claims it should have an additional three years of exclusive rights to sell Orenitram, which treats a blood-pressure disease affecting less than 0.01 percent of the population. The FDA approved the pill-based version of the drug in 2013, but did not award a full seven-year period of exclusivity because the company did not prove its oral formulation is superior to predecessors. United Therapeutics’ suit alleges that 2013 decision was unlawful, saying Orenitram should be protected by the Orphan Drug Act.
The company is also in talks with the Department of Justice, setting aside $210 million for a potential settlement over an investigation into whether the company’s contributions to patient-assistance charities violate a federal law against kickbacks. The government is investigating nine pharmaceutical companies, suspecting they are making payments to induce the use of their drug or product that is reimbursed by federal health programs, like Medicare.
Patients claim PBMs and pharmacies work together to charge patients more
Some patients are claiming that pharmacies and PBMs are selling drugs at a higher price to consumers paying with insurance than those who simply buy a drug outright. Two lawsuits have been filed alleging fraudulent charges by pharmacists, one against CVS and the other against Walgreens. One plaintiff claims that she bought a generic medication at CVS that cost $165.68 under her insurance but would’ve cost only $92 had she paid in cash without using her insurance – saying she had to find this out on her own because no one at CVS could legally give her a heads-up. The pharmacies dispute the allegations, noting copay costs for patients who use insurance are usually set by health plans, not pharmacies. Critics point out that pharmacists and PBMs negotiate payment agreements including copays and those negotiations are undisclosed to consumers.
Price negotiations create incentives for consumers to choose brand drugs
More than seven months after the generic was introduced, the more expensive brand-name EpiPen still accounts for more than one-quarter of the market, according to Bernstein Research. Some say it’s because a middleman can profit from the sale of pricier medicines, such as EpiPen. The complexity of the system and lack of pricing transparency can end up costing the country billions of dollars unnecessarily. Due to hidden and complex negotiations between drugmakers, PBMs and pharmacies, patients often find higher out-of-pocket costs for generic drugs than brand name versions. Consequently, many patients end up purchasing a brand name drug, which costs the consumer less but charges the insurer significantly more. Drugmakers and others in the industry say that PBMs can profit from costlier drugs because that means bigger rebates.
FDA targets opioids at postal facilities
The FDA is stepping up efforts to detect opioids illegally coming into the country via mail. Commissioner Scott Gottlieb said he is deploying 36 employees to international mail facilities to help pick out suspicious packages, and New Jersey Gov. Chris Christie called on the Trump administration to increase funding and staffing to stem the flow of drugs. Sen. Rob Portman (R-OH) is also advocating for a bipartisan bill called the STOP Act, which would require foreign postal services to provide electronic security data on all packages coming to the United States.
FDA plans educational campaign discouraging e-cigarettes
The FDA will launch an education campaign this fall to discourage e-cigarette use among young people, shortly after announcing it wants to lower nicotine levels in cigarettes to a non-addictive level. The agency will start releasing new digital material about the effects of nicotine on a teenager’s brain as part of “The Real Cost” campaign, which is estimated to have prevented 350,000 young people from starting to smoke from 2014 to 2016.
Pharmaceutical companies marketing opioids paid doctors $46 million
One in 12 doctors received payment from drug companies marketing opioids, according to a study published in the American Public Health Journal. More than 68,000 doctors received $46 million between 2013 and 2015, and about two-thirds of the payments came from speaking fees. Some of the states recording the most payment to doctors – Indiana, Ohio and New Jersey – are also hardest hit by the opioid crisis. Researchers found doctors were paid the most for promotion of fentanyl and companies did not aggressively market tamper-proof versions of pills.
States curb length of painkiller prescriptions as overdoses rise
At least 17 states have enacted rules to limit the number of painkillers doctors can prescribe. Some have passed laws limiting the duration of initial opioid prescriptions to five or seven days while others are passing dosage limits. Kentucky, where 1,400 people died of drug overdoses last year, capped opioid prescriptions for acute pain to three days. The CDC issued guidance to providers last year stating three days should be sufficient and more than seven days is rarely needed.