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Last year, the FDA once again set a new record for new drug approvals and far surpassed its 10-year average...Since being sworn in as FDA commissioner in 2017, Scott Gottlieb has made drug approvals a top priority for the agency. In 2018, the FDA made moves to streamline its entire drug approvals process — from early development to final application submissions...the FDA plans to continue removing barriers to generic drug competition by helping ensure access to brand-name biologic drug samples and cutting back on the number of review cycles companies have to go through to get generics approved...

CDER Drug Approvals

59 = New molecular entities approved...jump from the 46 approvals in 2017

64 = percentage of NMEs that were small molecules...20 percent...were antibodies.

34 = NMEs orphan drugs...that target rare diseases...

19 = approvals that were first-in-its-class therapies...

16 = Cancer drugs approved...

3 = New preventative migraine treatments...

73 = percentage of NME approvals that CDER expedited

971 = number of generics that were approved or tentatively approved...

State health officials gave legislators an overview of Nevada’s Medicaid program in an Assembly committee meeting...during which the program’s new administrator said the state program will be tackling a decrease in federal funding in coming years...“These rates are tied to the overall economy, so when the economy does better, we get a lower … rate from the federal government,” Suzanne Bierman, administrator...Department of Health and Human Services, said...The rate, called a federal medical assistance percentage, determines the share of Medicaid costs covered by the federal government. For the 2019 fiscal year, federal funds cover 65.09 percent of Medicaid costs...That number is expected to decrease to 64.17 percent in the next fiscal year...

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

Samantha DiGrande, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Critics often target physicians who receive money from pharma, but the exact influence those payments have on prescribing is up for debate. In oncology, at least, it’s not one-off payouts but consistent compensation that's most likely to sway prescribing behavior...the study showed that physicians who received payments over three consecutive years and tied to a specific drug boosted their prescriptions of that product. That pattern applied to oral drugs that treat lung cancer, kidney cancer and chronic myeloid leukemia...Among physicians who received payments from drug companies during only one year, no pattern emerged...

Johnson & Johnson will put list prices in its drug TV ads. It’s the first pharma to announce that plan, self-regulating ahead of a proposed Trump administration rule that would force all pharma companies to add list prices to TV commercials...J&J pharma arm Janssen will begin with its most prescribed drug, the oral anticoagulant Xarelto, adding both list price and potential out-of-pocket costs to its TV spots later this quarter. It will add prices to its other medicines, too, J&J said in a statement. It’s planning to weigh patient and consumer feedback on the Xarelto changes as it rolls out the follow-ups...J&J’s move combines the Health & Human Services list price mandate with the pricing principle plan that members of the trade association PhRMA agreed upon earlier this year. That plan would offer consumers a broader explanation of costs by linking ads to online or telephone explanations of expected out-of-pocket expenses and insurance coverage.

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Food and Drug Administration Commissioner Scott Gottlieb said he's putting pharmacy chain Walgreens "on notice" for allegedly selling tobacco products to minors...The agency has already filed formal complaints seeking to block a Walgreens' location in Miami and a Circle K Store in Charleston, South Carolina, from selling cigarettes or cigars for 30 days, citing "repeated violations."...Walgreens, the FDA noted, is currently the top violator among pharmacies that sell tobacco products. Some 22 percent of Walgreens locations inspected by the agency caught employees illegally selling tobacco products to minors...

Board Members
Leo Basch, PharmD, RPh, Las Vegas
Robert Sullivan, Reno
Jason Penrod, PharmD, RPh, Reno
Kevin Desmond, RPh, Reno
Wayne Mitchell, PharmD, RPh, Carson City
Melissa Shake, PharmD, RPh, Las Vegas
Jade Jacobo, PharmD, JD, RPh, Las Vegas

Retirement of the Executive Secretary
- Larry L. Pinson, PharmD, RPh

New Reno Office -
985 Damonte Ranch Parkway, Suite 206, Reno, NV 89521.

Board Member Update

Nevada Medicaid Initiates Antibiotics Prior Authorization Criteria - Nevada Department of Health and Human Services

National Pharmacy Compliance News

Final Guidance Documents Address FDA Policies Related to DSCSA

First FDA-Approved Drug Containing Extract From Cannabis Plant to Be Placed in Schedule V

ASHP Guidelines Provide Recommendations for Preventing Patient Harm From Medication Errors

FDA’s Final Guidance Documents Address Compounding and Repackaging of Radiopharmaceuticals

Pharmacy Toolkit Encourages Conversations With Patients About Prescription Opioids

Biosimilars Added to FIP’s Policy on Pharmacists’ Right to Substitute a Medication

FDA Offers CE Course on Reducing Hypoglycemic Events in Patients With Type 2 Diabetes - Leveraging Health Literacy and Patient Preferences to Reduce Hypoglycemic Events in Patients with Type 2 Diabetes

Drugmakers warned...that if Britain leaves the European Union without a deal next month Britons could miss out on an EU-wide system to fight counterfeit drugs that will go live on Saturday after years of British involvement in building it...Drugmakers, wholesalers and pharmacies across Europe have worked for more than four years on a system based on a shared database and tamper-proof packages with barcodes that will go live on Saturday, to fulfill the European Union’s Falsified Medicines Directive...“It would be an absolute travesty if NHS patients aren’t part of a system specifically designed to protect them. But that’s exactly what could happen in a ‘no deal’ Brexit,” Rick Greville, Director of Supply Chain at the Association of the British Pharmaceutical Industry, said in a statement by the lobby group...The European Medicines Verification System will allow dispensing pharmacists to scan drug packages and link up to a database to give patients assurance on the product’s authenticity.