Category:

The House is set to take up a controversial “right-to-try” bill next week — and if it passes, the Food and Drug Administration will have to work harder to protect patients than it would if a different version of the legislation were advancing, Commissioner Scott Gottlieb told STAT...right-to-try legislation aims to give terminally ill patients a different pathway to access experimental treatments that are not FDA approved...“In terms of making sure that it balances [access to experimental drugs] against appropriate patient protections, I think the Walden bill gives us less work to do,” Gottlieb said. “With the Johnson bill, we’d have to do a little bit more … in guidance and perhaps in regulation to achieve some of those goals, and I think those are the goals that Congress wants us to achieve.”

The U.S. Department of Justice has joined whistleblower litigation accusing Insys Therapeutics Inc of trying to generate more profit by paying kickbacks to doctors to prescribe powerful opioid medications...The government’s involvement...adds firepower to the civil litigation as Insys tries to resolve a federal probe into its marketing of Subsys, a spray form of fentanyl...Six U.S. states - California, Colorado, Indiana, New York, North Carolina and Virginia - also joined whistleblower litigation against Insys, according to the filing in U.S. District Court in Los Angeles...The litigation comes amid a wave of related criminal cases against medical practitioners, and former executives and sales representatives employed by Insys, including its billionaire founder John Kapoor.

A federal judge blocked the U.S. Drug Enforcement Administration from suspending a Louisiana drug distributor from selling controlled substances over allegations it failed to identify suspicious orders of opioids that were diverted for illicit uses...U.S. District Judge Elizabeth Foote in Shreveport, Louisiana, on Tuesday entered a temporary restraining order blocking the DEA from enforcing an order issued last week that immediately suspended Morris & Dickson Co’s registration...The DEA’s order marked the first time during President Donald Trump’s administration that it had moved to immediately block narcotic sales by a distributor as the agency attempts to combat a national opioid abuse epidemic...The DEA on Friday announced it was suspending the registration of privately-held Morris & Dickson, saying the distributor failed to properly identify large, suspicious orders of drugs sold to independent pharmacies.

The head of the Centers for Medicare and Medicaid Services said...it's time that health care catches up with other industries when it comes to providing consumers greater transparency about prices up front and easier access to their records and health data once they have received care..."We know that any other place in the economy you can know what things are going cost. Somehow in health care it's a big mystery," said CMS administrator Seema Verma...CMS issued a series of new proposals aimed at promoting greater interoperability of digital health-care records. They include forcing hospitals to post their prices online, and pushing them to transfer patients' discharge records to their doctors electronically, even if the doctors are not part of the same health system...Doctors who treat Medicare patients are already required to write prescriptions electronically. CMS now wants them to also make it easier for patients to access those records digitally...The administration's 2019 budget outline includes a proposal to give Medicare Part D plans for seniors more power to negotiate lower prices from manufacturers, and it initiates a pilot program that would allow state Medicaid programs to test drug formularies aimed getting more competitive prices...

With HHS Secretary Alex Azar by his side, President Trump...promised that “we are going to see prices go down, and it will be a beautiful thing.” Based upon the actual blueprint, which remains a work in progress, that may well be the case. But if it proves to be so, it will not be because the administration is wielding the metaphorical meat cleaver to cut prices by government edict and risk gutting our biomedical innovation engine...Instead...he appears to...endorse a series of incremental policy and market-based reforms that will eliminate many of the existing incentives that compel drug manufacturers to push list prices ever higher...These relatively modest proposals will not satisfy Democrats who remain fixated on adopting a single payer system where the Federal government can set prices, as is the case in western Europe. But then, it might be good to remember that risk capital and large drug companies are necessary to develop the compounds that are discovered in government and university research laboratories. If we wish to realize the promise of new medicines in treating rare diseases and in harnessing our immune systems to fight cancer, a thoughtful, cautious incrementalism is preferable to the harshness of the meat cleaver.

• Lower drug prices for older people
• Persuade other countries to pay more
• Require drug ads to include the price
• Ban ‘gag clauses’ for pharmacists
• End the patent games
• On the horizon

Legislation backed by the National Association of Chain Drug Stores to help address the opioid abuse epidemic was passed today by the House of Representatives Energy and Commerce Committee. The bill – the Every Prescription Conveyed Securely Act (H.R. 3528) – would require electronic prescribing for Schedule II through V controlled substances prescriptions covered under Medicare Part D to help prevent fraud, abuse and waste...Leveraging the benefits of electronic prescribing to help address the opioid abuse epidemic is one of the priority policy recommendations of NACDS, based on the experiences of pharmacists on the front lines of healthcare delivery.”...The concept of the Every Prescription Conveyed Securely Act maintains strong public support. In a January 2018 national survey conducted by Morning Consult...76% supported rules that all prescriptions must be handled electronically, rather than by paper or fax, as a way to help address the opioid abuse epidemic...The Senate companion legislation of the Every Prescription Conveyed Securely Act is S. 2460, introduced by Sens. Michael Bennet (D, Colo.) and Dean Heller (R, Nev.)...would need to be passed...prior to its proceeding to President Trump for consideration and signature...

The U.S. Food and Drug Administration...listed a number of drugmakers it said could be improperly blocking access to their medicines in order to delay generic competition...But many of the companies immediately pushed back, saying the FDA list of drugmakers may be out of date and that some of the drugs included on it already have generic competitors...The FDA said the list contained all of the inquiries about drugs it had received from generic drugmakers since 2005. It said companies generally do not inform it if they have made samples available after a generic developer has reached out to the agency...The agency said companies on the list may be using FDA safety regulations and other tactics to deny access to their medicines from generic drugmakers hoping to copy them...The FDA is notifying the Federal Trade Commission, which can investigate anti-competitive acts, of cases where drugmakers may be blocking access to their products if there is no safety reason...

The Centers for Medicare & Medicaid Services launched its first "Rural Health Strategy"...an effort, officials said, to better consider the rural impact as part of the of the agency's work...The strategy, which highlights tactics such as improving access to telemedicine, is meant to avoid unintended consequences of policy and program implementation in rural health settings...“Through its implementation and our continued stakeholder engagement, this strategy will enhance the positive impacts CMS policies have on beneficiaries who live in rural areas," said CMS Administrator Seema Verma in a statement...CMS said it is changing access to telehealth services, particularly in rural areas, by paying for additional services and making it easier for providers to bill Medicare..."Something that our organization has been promoting and pushing for quite a while is we just want CMS internally, before they promulgate any rules, to take a look at the impact on rural providers and communities," said Alan Morgan, CEO of the National Rural Health Association...

...Drug Enforcement Administration said...it had suspended a Louisiana pharmaceutical distributor from selling controlled substances for allegedly selling unusually large quantities of opioids to pharmacies without reporting the sales...Morris & Dickson Co...investigation showed “it failed to properly identify large suspicious orders for controlled substances sold to independent pharmacies with questionable need for the drugs.”...Morris & Dickson filed in federal court...an injunction against the suspension, and U.S. District Judge Elizabeth Foote in Shreveport has scheduled a hearing...on its request for a temporary restraining order...The probe, which focused on purchases of Oxycodone and Hydrocodone, showed that in some cases, pharmacies were allowed to buy as much as six times the quantity of narcotics they would normally order...