- 6 Takeaways From Trump’s Plans to Try to Lower Drug Prices (nytimes.com)Rest easy, pharma. Word is, Trump's drug pricing plan won't be a tough pill to swallow (fiercepharma.com)
- 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
- NACDS-backed e-prescribing bill to fight opioid abuse passes (chaindrugreview.com)
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...
- U.S. drug agency suspends Louisiana distributor over opioid sales (reuters.com)
...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...
- In a blow for pharma, Supreme Court upholds the hated IPR patent challenge (fiercepharma.com)
Branded drugmakers have said "no fair" to the U.S. Patent and Trademark Office's inter partes review system almost since its inception seven years ago. One reason? "It's unconstitutional," the companies contend...The Supreme Court...disagreed...In a 7-2 vote, the U.S. High Court held that the system is constitutional. It doesn't violate Article III of the Constitution, which gives the judicial branch alone the power to decide legal arguments. Nor does it violate the Seventh Amendment, the right to a trial by jury...It's a limited ruling specific to the issues in this particular case, Oil States Energy Services v. Greene’s Energy Group...Justices John Roberts and Neil Gorsuch dissented, saying only an independent judge—not a political appointee at the PTO—should be able to revoke patents, which they equated with personal property such as a home or a farm...PhRMA...said the "narrowly tailored decision" found only that IPRs are constitutional, not "efficient or fair." The arguments and a...ruling in another case—SAS Institute v. Iancu—mean it's "clear there are problems with the IPR process that need to be addressed,"...
- Major drug distributors downplay contribution to opioid crisis in testimony before Congress (cbsnews.com)
The heads of five major drug distribution companies downplayed their contribution to the opioid crisis...while testifying before a Congressional subcommittee tasked with investigating the epidemic spurred by abuse of opioids. Their testimony drew bipartisan wrath and one Republican suggested prison terms for some company officials...Miami-Luken CEO Joseph Mastandrea told the House panel that his company played a role in the opioid crisis, but executives from the other four drug distributors demurred saying the responsibility lied with prescribers and pharmacists more than it did with distributors...While distributors have been responsible for reporting suspicious orders for more than 40 years, some told members of Congress their screening systems had failed...AmerisourceBergen, Cardinal Health, and McKesson -- often known as the big three drug distributors, shipping 80 percent of prescription drugs in the United States, say their current systems for detecting suspicious orders has been greatly improved in recent years, relying more on algorithms to automatically detect issues...
- As Opioid Liability Rises, Accreditor Seeks Credential For Pharma’s Educators (forbes.com)
The effort to set standards and credentials by the Accreditation Council for Medical Affairs comes during an intense period of scrutiny for those who educate and interact with prescribing physicians. Everybody from federal, state and local lawmakers to plaintiffs’ attorneys are taking aim at the pharmaceutical industry and its marketing practices...Doctors have been accused of overprescribing opioids and critics say pharmaceutical marketing contributed to unnecessary prescriptions...“The opioid crisis is the impetus that sheds the light on pharmaceutical sales practices,” Accreditation Council for Medical Affairs founder and chair William Soliman said. “There are no minimum standards. It’s a crapshoot because nothing’s been uniform.”...Last year...the City of Chicago implemented a new “pharmaceutical representative license” designed to create “greater oversight of prescription marketing...to prevent deceptive drug marketing.”...ACMA has been approved as the provider of continuing education to support license renewal for Chicago’s mandatory pharmaceutical representative credentialing program...ACMA has grown globally to accredit more than 4,000 pharmaceutical reps and medical affairs professionals...
- FDA chief questions protections on drug rebates, stocks fall (reuters.com)
...Food and Drug Administration chief Scott Gottlieb....questioned whether rebates that drugmakers provide to health insurers should remain protected by federal law, sparking new concerns on Wall Street over efforts to curb drug pricing...Gottlieb was referring to the common practice of pharmaceutical companies setting a high “list price” for a drug, and then lowering the cost for health plans through hefty rebates in exchange for the broadest access to patients. In recent weeks, he has criticized these practices for keeping drug prices high and locking out competitors...“What if we took on this system directly, by having the federal government reexamine the current safe harbor for drug rebates under the Anti-Kickback Statute?”...“Such a step could help restore some semblance of reality to the relationship between list and negotiated prices, and thereby boost affordability and competition.”...The anti-kickback law makes it illegal to pay an incentive for drugs or services that Medicare, Medicaid or other federal healthcare programs cover...
- Centers for Medicare & Medicaid Services to consider future policies through ‘rural lens’ (fiercehealthcare.com)
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...
- Supreme Court hears arguments on untested lethal injection method for inmate who’s asking to die (thenevadaindependent.com)Nevada Supreme Court overturns lower court ban on using a paralytic in Scott Dozier execution, citing procedural issues (thenevadaindependent.com)
The Nevada Supreme Court heard oral arguments...in the case of a death row inmate who wants the state to put him to death with a lethal injection method never before used in Nevada or elsewhere...Scott Raymond Dozier, 47, is a death row inmate convicted in Clark County of the 2002 killing and dismemberment of Jeremiah Miller...also...has repeatedly expressed his desire to give up his appeals and be put to death...Dozier’s lawyers are particularly concerned that the execution protocol calls for a paralytic (cisatracurium) in addition to two other drugs (fentanyl and diazepam) meant to kill the defendant...the paralytic doesn’t serve a medical purpose but is only included to mask signs of distress, potentially hiding any indicators of a painful or botched killing...The issue the court must decide is whether the state’s use of the paralytic in the execution violates Dozier’s right, under the Nevada and U.S. constitutions, to avoid any cruel and unusual punishment...
- Drug co-pay groups: Critical patient charities or fronts for drugmakers? (usatoday.com)
Co-payment assistance groups, created to help patients with the increasingly higher price of drugs...are under investigation by federal authorities for possibly skewing the cost of health care to favor drug companies...Critics of these groups, such as Patients for Affordable Drugs...say they drive up the cost of health care by masking the price of drugs and forcing higher costs on the insurance companies that pass them along to consumers and employers...The money to pay for the groups’ support of patients comes almost entirely from the drug companies themselves or other charities they fund...These groups are a marketing arm of pharma, and the fact that patients are caught in the middle...The U.S. attorney in Massachusetts and the Health and Human Services inspector general have been investigating this insurance co-payment assistance for more than three years...It's illegal under federal "anti-kickback" law for drug companies to pay patients' Medicare drug co-pays, and any patient group that covers these co-pays can't steer consumers to their pharmaceutical donors' drugs...the Justice Department reached a settlement agreement with drugmaker United Therapeutics...The government accused UT of paying kickbacks to Medicare patients through a charity, Caring Voice Coalition, "that held itself out as an independent charitable foundation." The drugmaker paid $210 million to resolve the allegations, and the Justice Department rescinded an advisory opinion it issued CVC because the group "allowed its drug company donors to funnel money through CVC in potentially illegal ways that served the drug companies’ financial interests."