ACHP Media Report: Pharmacy News – August 4, 2017

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Drug cost conversation continues

Import bill could save U.S. more than $6 billion
A bill to import drugs from Canada is estimated to save the government more than $6.8 billion over the next 10 years, according to a preliminary report by CBO. The bill would allow individuals and wholesalers to import drugs and would prevent drugmakers from restricting drug supplies to Canada or from hiking prices on Canadian pharmacies. A recent poll by KFF found two-thirds of Democrats and three-quarters of Republicans favor the idea. While the idea is popular, some drug experts believe drug importation could pose a health risk to Americans. Prior to his position as FDA Commissioner, Scott Gottlieb criticized the idea of drug importation and four former FDA Commissioners have expressed concerns about drug safety. The FDA has not formally commented on the bill. .

Rare disease drug costs patients $750,000 in the first year
Patients with a rare disease called spinal muscular atrophy, or SMA, often find themselves without muscle strength, affecting their ability to sit, stand and sometimes breathe. However, private insurers and state Medicaid regulators across the country have been debating whether to cover treatment for SMA due to cost. The SMA drug Spinraza has an exceptionally high price tag of $750,000 for the first year of drug doses. Pharmaceutical company Biogen says Spinraza is comparably priced to other rare disease drugs, and the company covers the cost of the drug for some patients through its assistance program.

Lack of competition in generic drug industry slows savings
The generic drug market is struggling to maintain robust marketplace competition. In addition to pharmaceutical companies’ tactics to suppress generic competition, thin profit margins make it difficult for small companies to absorb challenges like active ingredient shortages or manufacturing delays. A GAO report last year found many generic drugs had at least one price surge in a five-year period and according to the FDA, over half of approved generics are not being sold.

Websites aim to lower costs of prescription drugs
Websites like GoodRx, which tracks prices and discounts for 70,000 local and mail-order pharmacies, help consumers find cheaper prescription drug options. GoodRx, pharmacy-benefit manager Express Scripts and eight major drug companies created a program called Inside Rx to lower prescription drug costs for patients without insurance or with high deductibles. The program works directly with pharmaceutical manufacturers to give discount cards to eligible patients for certain medications. Another website, Blink Health, groups patients’ prescriptions together to ramp up purchasing power to secure lower prices.

Video explains pharmacy benefit managers’ role in drug pricing
Kaiser Health News created a video to explain the role of pharmacy benefit managers in the rising costs of prescription drugs. These multimillion-dollar corporations are not well understood by patients, but play a significant role in medication pricing.

FDA Happenings

FDA user fees reauthorized with passage of “right-to-try” bill
The Senate reauthorized four FDA user fee agreements, which fund the FDA’s prescription drug and medical device review processes for the next five years. The agreements were set to expire at the end of September. Other bill provisions include prioritizing generic drugs approval and expanding oversight of medical devices post-approval. The Senate also approved legislation that allows patients to try experimental treatments still under review by the FDA. It prohibits the government from denying terminally ill patients drugs that have completed at least one preliminary trial, effectively barring the FDA from overruling 37 states with “right-to-try” laws already in place.

FDA wants to cut smoking
The FDA announced goals to lower nicotine in traditional cigarettes to a non-addictive level and better regulate e-cigarettes. FDA recently postponed a compliance deadline for e-cigarette companies to provide more information to the agency. Commissioner Dr. Scott Gottlieb says the FDA will strengthen efforts to prevent kids’ use of nicotine products and is seeking public input on how to best achieve its objectives and avoid creating a black market for full-nicotine cigarettes.

Opioid epidemic

Commission finds states need to share prescription data to combat opioid crisis
A White House commission called on President Trump to declare the opioid epidemic a national emergency and recommends the federal government provide funding to states to improve data sharing between their prescription drug monitoring programs (PDMPs). The commission found most states underutilize databases, don’t share data with each other and do a poor job sharing information with physicians, which is critical to identifying which patients are abusing opioids. The Commission recommends HHS have all state and federal PDMP systems share information by July 1, 2018.

DOJ launches unit to detect opioid fraud and abuse
Attorney Jeff Sessions announced the creation of a pilot program to analyze data on opioid prescriptions to better detect abuse. The Opioid Fraud and Abuse Detection Unit will hire 12 new assistant U.S. attorneys to focus on prosecuting doctors, pharmacies and medical providers dispensing a disproportionate number of opioid pills. The unit will include a data analytics program to identify who is prescribing at higher rates.