The Institute of Clinical and Economic Review's (ICER) final evidence report on the benefit of abuse-deterrent formulations (ADFs) of opioid painkillers concludes that the evidence is inadequate to demonstrate the formulations are effective in reducing the overall abuse of opioids in the U.S. Since the formulations focus on making the drugs more difficult to crush, snort or inject, they do nothing to counter the most common route of opioid abuse, which is swallowing more pills. ICER also found little evidence on the impact of ADFs on abuse in clinical practice, but it cites evidence suggesting that the formulations can lead those trying to abuse the drug to switch to other, potentially more dangerous drugs, such as heroin and fentanyl. The report points out the economic impact of state legislation encouraging the rapid replacement of all opioids with the more expensive ADFs, noting that broad substitution could prove unaffordable for many health systems and divert resources needed for other health care efforts to address the opioid crisis. Every 100,000 individuals prescribed an extended-release ADF opioid could result in a net $533 million increase in costs over five years, according to the report. It encourages manufacturers and payers to commit to making ADFs affordable by moderating monopoly pricing power and reducing barriers such as increased out-of-pocket payments for patients. In another recommendation, ICER suggests a change in terminology to "tamper-resistant formulation" to avoid misunderstanding about the addictive and abuse potential of ADFs.

In the continuing saga over drug pricing, a class-action lawsuit was filed Monday in federal district court in Rhode Island against CVS Health alleging that the company colluded with pharmacy benefit managers (PBMs) to increase profits by driving up generic prescription drug costs through copays for consumers who purchase the drugs using insurance. The suit alleges that the copays exceed the pharmacy's price and profit and a significant portion of it is kicked back to the PBM under a confidential agreement. As another part of the scheme, customers using their insurance to fill prescriptions at CVS are charged a higher price for the same drug than those paying with cash, according to the suit. The lawsuit claims that the hidden fraud violates federal racketeering laws and that the agreements are fraught with fraudulent concealment, fiduciary conflicts of interest, lack of adequate care and violations of state consumer rights laws.

The FDA is releasing a draft guidance describing the chemistry, manufacturing and controls (CMC) postapproval manufacturing changes that it generally considers to be minor changes that have little potential to adversely affect the safety or efficacy of specific biologics. Under FDA regulations, such minor changes in the drug, production process, quality controls, equipment, facilities or responsible personnel must be documented in an annual report. The guidance discusses what should be included in the annual report notification and provides examples of postapproval CMC changes for biologics that would be considered to have minimal potential to impact the identity, strength, quality, purity or potency of the drug. Comments on the draft are due by Oct. 8.

Responding to an increased demand for the repackaging of solid oral drugs into unit-dose containers, the FDA revised its draft guidance on the expiration dating of the repackaged product to decrease the regulatory burden on manufacturers while still ensuring patient safety, according to a notice slated for publication in Wednesday's Federal Register. The revised draft describes the conditions under which the agency does not intend to t1.2083 inake action regarding required stability studies for the repackaged products and discussed the expiration date that should be assigned in such situations. The draft shortens the expiration date to be used under certain conditions from 12 months to six months or 25 percent of the time remaining until the expiration date on the original container, whichever time period is shorter. However, it provides for a longer expiration date with supportive data from appropriate studies. Products repackaged by state-licensed pharmacies, federal facilities and outsourcing facilities are excluded from the scope of the guidance. The comment deadline is Oct. 8.