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ACHP Resources: ACHP has released the latest installment in The Spike in Drug Prices infographic series, focusing on the troubling spike in the cost of generic drugs. Generics have helped patients save money by providing a low cost alternative, but in a troubling shift, paired with a lack of competition in the marketplace, some generics are as pricey as brand drugs. Transparency can help increase competition in the marketplace and help consumers make better choices about their health care. More information here. Please share widely!
Trump considers executive order on drugs
President Trump will meet with HHS Secretary Tom Price and White House budget director Mick Mulvaney today to discuss a possible executive order targeting drug prices. The executive order will likely not have a significant impact on the pharmaceutical industry, but more so be a step towards future drug pricing reforms. The executive order is expected to be released in the coming weeks; possibly before Congress’ recess on July 4.
FDA looks to advance digital technology
FDA commissioner Dr. Scott Gottlieb is launching a new initiative with a goal of getting medical applications and digital technology advancements to the market faster. Through the new initiative, the FDA would streamline its premarket review process and allow third parties to certify new technology that are not high risk.
Drug cost conversation continues
AMA tackles price transparency
The American Medical Association (AMA) approved a resolution that requires drug manufacturers disclose the retail price of drugs in their direct-to-consumer advertisements. The goal of the resolution is to improve price transparency and encourage the Federal Trade Commission, Federal Communications Commission and the FDA to require price disclosures. Critics argue the resolution will not pass as it may violate the First Amendment.
Victory in biosimilar marketing
The U.S. Supreme Court reversed a U.S. Court of Appeals decision on allowing biosimilars to enter the market. Biosimilar manufacturers now do not need FDA approval to begin the process of getting their versions of biotech drugs to market and are not required to provide the company owning the original biologic 180-day notice. This decision is a victory for biosimilar applications and specifically for Sandoz, which is aiming to market a biosimilar of a drug manufactured by Amgen.
Nevada makes drug transparency law
Governor Brian Sandoval signed into Nevada law a requirement for drug manufacturers to disclose how they set prices for insulin drugs. The law stipulates drug companies disclose annual list prices, profits from their insulin products and discounts given to PBMs. In addition, the law requires a written explanation for insulin price increases that exceed the inflation rate or are greater than twice the inflation rate of the past two years.
Lawmakers fail to make progress on drug prices
The first in a series of Senate HELP committee hearings on drug prices failed to progress past partisan disagreements around efforts to repeal the ACA. The hearing provided few insights into potential legislation and did not offer any bipartisan agreements on potential approaches to the issue. Much of the conversation focused on the drug delivery system rather than the crux of the issue, drug affordability.
FDA questions abuse-deterrent formulations
The FDA is investigating whether or not abuse-deterrent opioid formulations are making a significant impact on curbing the opioid epidemic. The FDA will hold a public workshop from July 10-11to discuss the challenges in assessing the impact of abuse-deterrent properties on opioid misuse, abuse, addiction, overdose, and death.
Varied approaches to address the epidemic
As the opioid epidemic continues and state budgets are stretched, state and local leaders are studying tactics used in lawsuits against big tobacco in the 1990s. More than 20 states have filed lawsuits against drug companies alleging that they have knowingly contributed to the public health crisis through misleading marketing and aggressive sales tactics. Two decades ago, big tobacco faced similar allegations as states and local governments sued, saying they’d shouldered huge costs for treating diseases blamed on tobacco.
A white paper released by the national databank FAIRHealth explores how states differ in their medical responses to the opioid epidemic. The paper shows that patients with private insurance who are diagnosed with opioid dependency or abuse may get different medical services depending on where they live.
To change prescribing habits, one nonprofit is employing the same tactics drug companies used to get doctors to prescribe in the first place – one on one provider education. Volunteers are educating physicians on opioid prescribing guidelines, providing strategies on handling patients demanding pills and information on alternative treatments. To date, physicians appear to be receptive to these efforts.