October 27, 2017
Drug Pricing Discussion Continues
Utah legislature may take up importation
State representatives in Utah will introduce a bill to allow the state to import prescription drugs from Canada. The legislation would let the state designate an existing wholesaler to purchase prescription drugs from a Canadian wholesaler. It would set up a chain of custody that is the same as would be for U.S. distribution: setting up a program, filling out paperwork and getting approval from HHS, whose approval is required under federal law. While the bill is aimed at making lower-cost drugs available, it is likely to receive pushback. Some argue that importation could lead to counterfeit medicines on the market.
Trade groups spend record amount lobbying
The drug industry trade groups PhRMA and BIO are set to spend a record amount on lobbying efforts this year. In the first nine months of 2017, the two groups together spent more than $26 million, more than any year since groups began reporting their quarterly lobbying spending in 2008. Some of the issues the groups are focused on include CHIP funding, drug rebates, biosimilars and the opioid crisis.
Opinion: Profit margins suggest drugmaker R&D defense is misleading
LA Times columnist Michael Hiltzik is challenging pharmaceutical companies’ claim that drugmakers need big profits to continue to develop innovative new treatments using Gilead as an example. Hiltzik cites Gilead’s decision to use 100 percent of its $13.5 billion in profits from 2016 for stock buybacks and dividend payouts are evidence that profits are rarely reinvested for research purposes. Hiltzik takes a deeper look at the cost of high-priced specialty drugs, drugmaker claims for the high prices and what actually goes into drug development.
CVS in negotiations to buy insurer Aetna
CVS is in discussions to purchase Aetna and has made an opening offer that values the insurer at more than $200 a share, a $66 billion offer. The move would provide CVS with a broader customer base and give the pharmacy company a stronger position when negotiating prices with drugmakers. The move also mirrors a broader push by CVS to expand health care offerings, including urgent-care services. Discussions are still preliminary and no deal has been reached between the two companies, but discussions are ongoing (subscriber’s content).
Gottlieb looks to increase medication-assisted treatment options
During a House hearing this week, FDA Commissioner Scott Gottlieb announced steps to promote the use and development of new medication-assisted treatments (MAT) for substance use disorder. Gottlieb outlined a three-pronged approach: The FDA will issue guidance for developing new MAT treatments, increase efforts to reduce stigma and promote alternative therapies. Some clinicians are skeptical that MAT alone will have a significant impact, saying the underlying behavioral health and socioeconomic issues tied to opioid use disorder also need to be addressed. Expanding access to MAT was among the White House commission’s key recommendations in its interim reports.
FDA guidelines on office-use compounding draws complaints from pharmacists
Some pharmacies believe the FDA is overstepping its authority and jeopardizing patient access to treatments by not allowing office-use compounding. Office-use compounding is when pharmacists prepare a drug without a prescription and send it to a doctor to keep on hand for when a patient might need it. Compounding pharmacies believe the FDA is misinterpreting the purpose of the Drug Quality and Security Act and that the agency has created confusion by creating unenforced guidelines on office-use compounding.
The Opioid Epidemic
Trump declares opioid crisis public health emergency
President Trump has declared the opioid crisis a public health emergency which does not release any additional federal funds to fight the epidemic, but does allow existing funds to be used in different ways. The designation will allow the suspension of a law that prevents Medicaid from being reimbursed for addiction treatment at certain facilities and allows limited amounts of grant money to be used for opioid abuse. It also permits the government to hire additional specialists, gives states more flexibility in how they use federal funds and expands telemedicine treatments. Trump also indicated that his plan would require federally employed prescribers to undergo training and an initiative to develop alternatives to opioids. Federal authorities also plan to intensify efforts to prevent illegal shipments of fentanyl, especially from abroad. Addiction experts say the declaration is a good first step, but dedicated federal funding from Congress will be necessary to adequately address the crisis.
Prosecutors investigate Purdue marketing claim
Federal prosecutors are looking into Purdue Pharma Inc.’s claim that OxyContin provides 12 hours of pain relief. A LA Times investigation last year suggested that Purdue ignored evidence that OxyContin’s effects do not last 12 hours in some patients, increasing the risk of withdrawal, misuse or addiction. Purdue spearheaded aggressive marketing techniques that contributed to OxyContin’s popularity, and several government lawsuits now seek to hold the company accountable for its marketing practices. Purdue is cast as the main villain in a wave of government lawsuits seeking to hold opioid makers and distributors responsible for the opioid epidemic. Ten states and dozens of cities and counties have sued drug companies alleging that they triggered the epidemic by minimizing the addiction and overdose risks of painkillers.
Senators introduce legislation aimed at fighting the opioid epidemic
A group of 15 U.S. Senators introduced a bill to allot $45 billion to fight the opioid epidemic through long-term investments in prevention, treatment, recovery and monitoring. According to some advocates and lawmakers, significant federal funding is needed for an effective response to the opioid crisis. Last year, the 21st Century Cures bill provided $1 billion over two years to fight the crisis.
Addressing the underlying causes of opioid misuse
Combatting the opioid epidemic could require more than just medical intervention. Unemployment, lack of health insurance and poverty are all correlated with opioid misuse, and areas with fewer options for upward mobility have been the hardest hit. Countering the epidemic requires a multipronged approach, expanding access to treatment and rethinking treatments for pain. However the joblessness and poverty often associated with regions where addiction is prevalent can’t be helped by medical solutions. Addiction often reflects deep-seated social and economic ailments. Economic rehabilitation could be needed to address the social and financial factors that play a role in the opioid epidemic.
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