ACHP Media Report: Pharmacy News – August 25, 2017

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Smart pill bottles aim to provide more effective medication reminders
Research suggests that about half of all patients fail to follow prescription instructions, resulting in at least 100,000 deaths and hundreds of billions in unnecessary health care spending each year. Most patients simply forget to take their required treatment. Health technology companies have begun selling smart pill bottles as reminder devices; many provide visual or audio reminders and some will detect if a patient has not taken his or her medication and alert physicians or caretakers. While an increasing number of patients are interested in these tools, there is evidence they may not be any more effective than traditional daily pill boxes.

Drug cost conversation continues

Michigan legislature weighs drug price legislation
State lawmakers in Michigan will soon introduce a bill aimed at curbing spikes in drug costs. The legislation would create a state agency responsible for reviewing prescription drug price hikes. Drugmakers that raise prices by more than 10 percent in a year or 30 percent in five years would have to justify the increase or face a $500,000 fine. The bill is similar to laws in Nevada, Maryland and Vermont.

Leukemia drug could revolutionize treatment but at high cost
A new drug could revolutionize treatment for leukemia patients— but cost hundreds of thousands of dollars for a single dose. The drug, CTL019, genetically alters a patient’s immune cells in order to kill cancer, and provides a treatment option for patients who have relapsed despite chemotherapy or a bone-marrow transplant. Eighty-three percent of patients treated with CTL019 have gone into remission. A price for the drug has not been set, but British health authorities say the drug company could justify a price as high as $649,000 for a single treatment.

A repackaged cancer drug is being prescribed for MS at 10 times the price
Despite evidence that the cancer drug Rituxan could be an effective treatment for multiple sclerosis, the drug manufacturer never attempted to sell the drug to treat MS. Instead, they made minor adjustments to Rituxan, secured a new patent, and launched the new drug Ocrevus, a treatment for multiple sclerosis that experts believe is slightly more effective and easier to administer than Rituxan would have been, but that costs 10 times what Rituxan costs.

FDA Happenings

FDA push for over-the-counter drug review
For the first time, the FDA is considering “user fees” for the review and approval of over the counter (OTC), non-prescription products much like the user fee program for prescription drugs. The additional industry fees would provide the FDA with more funding for a larger staff, which would enable the agency to evaluate changes to existing products more quickly. The FDA estimates the fees could amount to $22 million in their first year.  Important consumer safety questions remain on FDA’s ability to quickly review meaningful changes to pre-approved ingredients, dosage and labeling for particular product categories in over the counter drugs. Consumer groups are advocating for so-called “monograph reform” to address the issue, and drug manufacturers support the change (subscriber’s content).

Johnson & Johnson pays out more than $400 million in talc case
A jury has awarded $417 million to a woman who sued Johnson & Johnson for inadequately warning consumers about the dangers of talcum powder use. The plaintiff, who has ovarian cancer, hopes the decision will force Johnson & Johnson to put additional warnings about cancer risks on product packaging. Johnson & Johnson plans to appeal the decision and reasserted that scientific evidence backs its claim that using talc is safe. The FDA has not weighed in on the safety of talcum powder and cannot require the product to carry a warning label as it is classified as a cosmetic.

Opioid epidemic

Fake treatment centers exploit opioid patients for insurance fraud
Fraudulent treatment centers are exploiting patients suffering from opioid use disorder in order to make money. Fraudsters establish clinics that claim to help treat patients but instead some are employing tactics that reinforce the addiction or create false positive drug tests in order to prolong treatment and increasingly bill insurance companies. A number of state and federal laws make oversight difficult, including protections for patients under the Americans With Disabilities Act and health privacy laws. However, states are trying to combat the issue. Florida, a state where many fraudulent treatment centers have operated, has passed tougher penalties for patient brokering and limited new marketing techniques.

Maine’s tough opioid restrictions may be model for other states
Maine has enacted a law implementing stringent restrictions on opioid prescriptions by placing the lowest cap on dosages in the nation. The move reinforced already-dropping prescription rates for opioids, which fell by 21.5 percent from 2013 to 2016. While the law has been hailed as a success by many, some physicians have challenged the restrictions and the state has revised the law to include exemptions for chronic care patients. Despite these concerns, many states are considering emulating Maine’s restrictions.

Trump yet to declare opioid crisis as emergency
Despite publically stating the opioid crisis is a national emergency, President Trump has not yet made a formal declaration, which is required for expanded powers. Categorizing the opioid crisis as a public health emergency would allow HHS Secretary Tom Price the ability to issue grants, spend money and amend regulations beyond his typical power.