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Draft executive order benefits PhRMA
Trump’s draft executive order on drug pricing appears to focus on alleviating regulations for drug companies that would lead to faster approvals in an effort to lower drug prices. Proposals include strengthening trade agreements for American drugs sold overseas and scaling back federal programs requiring drug discounts for hospitals and clinics serving low-income individuals, both of which benefit drug companies. Congressional Democrats say the proposal is a giveaway to the drug industry, and Reps. Elijah Cummings (D-MD) and Peter Welch (D-VT) sent a letter asking the President to call for more aggressive reform.
Biotech stocks are on the rise after reports suggest the draft executive order will benefit drug companies. The Nasdaq Biotech Index has had its best three-day run since November.
FDA to get drugs to market faster, approves MS drug
Dr. Scott Gottlieb, FDA Commissioner, has scheduled a hearing for July 18 to address tactics brand drug manufacturers have used to prevent generic drugs from entering the market. The hearing is another step by the FDA to actively address the issue of high priced drugs and improve market competition.
Gottlieb has also pledged to eliminate the backlog of 200 orphan drug designation requests at the FDA. He noted the agency plans to release modern, risk-based tools to assess these drugs, developing a streamlined and quicker evaluation process.
The FDA has approved the start of human trials for a drug to treat advanced multiple sclerosis in the United States. The Australian biotech company Innate Immunotherapeutics, whose largest shareholder is Rep. Chris Collins (R-NY), has already completed preliminary trials in other countries. Drugs to treat multiple sclerosis are among the most expensive in the U.S., costing about $60,000 per year. An investigation is underway to determine Collins’ role.
Drug cost conversation continues
PhRMA continues strong policy influence
Despite pressure to rein in drug prices, the pharmaceutical industry remains influential on policy. The 10 largest pharma companies that lobby in the U.S. spent more than $20 million combined on lobbying efforts in the first three months of the year. As a reauthorization bill for drug makers’ funding agreements with the FDA makes its way to the President’s desk, the pharmaceutical industry is working to keep the legislation free of major policy changes. The executive order on drug prices could also be a win for the pharmaceutical industry, as documents suggest it will be favorable to the industry.
Drug sales decline
Continued pressure on the price of drugs in the U.S. has impacted the expected global revenue from drug sales. Evaluate Pharma predicts global drug sales will decline to $1.06 trillion in 2022, lower than last year’s prediction and the first decline in 10 years.
States get help to fight drug pricing
The National Academy for State Health Policy launched its Center for State Rx Drug Pricing which will provide states resources and traverse the issue of drug pricing. Funded by the Laura and John Arnold Foundation, states will participate in shared learning and have the opportunity to advance drug pricing proposals through grants from the organization.
GOP health plan could worsen opioid epidemic
Former U.S. Surgeon General Vivek Murthy warned that the Republican health care plan would worsen the opioid epidemic. Medicaid cuts and states’ ability to opt-out of essential benefits that cover treatment could make access harder for those who need it.
AMA supports supervised injection sites
The American Medical Association (AMA) approved a resolution to develop a pilot on supervised injection facilities (SIF). SIFs provides drug users a safe site to inject drugs, staffed with medical personnel. Proponents of SIFs note they lead to fewer drug overdoses, reduced transmission of infectious diseases and encourage individuals to seek treatment. Critics claim SIFs enable continued drug use. State restrictions in California, New York and Washington may hinder the AMA’s ability to pilot SIF initiatives.
Report: Opioid use increases hospitalizations
The Agency for Healthcare Research and Quality (AHRQ) released a report that notes between 2005 and 2014, inpatient care for opioid-related issues increased by 64 percent and emergency room utilization increased by 99 percent. As the opioid epidemic continues, the trend is expected to increase.
Overprescribing of opioids in Medicaid
Pharmacy benefit manager, Express Scripts, released a report that notes nearly 6 percent of all scripts written in 2015 for Medicaid beneficiaries were for an opioid, totaling around $90.1 million. In addition, 28.5 percent of these individuals were prescribed more than a month’s supply of medication.
Young adults continue to suffer
A study released in JAMA Pediatrics explains that young adults suffering with opioid addiction are not receiving the needed treatment despite having health insurance. Of the 21,000 patients studied, only 27 percent received buprenorphine or naltrexone to treat their addiction. In addition to the severe treatment gap, researchers also found minority populations had an even lower likelihood of receiving treatment.