Author: Peter

...In too many cases, branded drugs that are no longer protected by patents or other exclusivities do not face expected competition. In fact, there are several hundred of such branded drugs that do not have any generic competition. Instances like these may keep prices high and ultimately hurt American patients...We’ve been taking new policy steps at the FDA to support downward pressure on drug prices by helping to clear a path for more efficient generic development...We’re working to reduce barriers to generic development and to lower the cost of generic entry so that more of the generic medicines that the FDA approves are launched and reach patients...

- issue draft guidance with recommendations on establishing active ingredient sameness.

- development of new analytical tools and in vitro tests to provide additional accurate, sensitive and reproducible tools to support approval of complex generic drugs.

- laying out new, efficient guidelines for the use of a novel pathway that provides incentives for developing generic versions of drugs that currently face little or no competition - Competitive Generic Therapies

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.

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...

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...

Under a proposal...Medicare would cover CAR-T cell therapies through a Centers for Medicare and Medicaid Services pathway known as Coverage with Evidence Development...The proposal holds a mix of provisions, including that patients must be monitored for at least two years post-treatment. Hospitals administering CAR-T therapy, whether through inpatient or outpatient care, must participate in a CMS-approved registry that collects data on patient outcomes and characteristics and then compares that data to what's been seen in pivotal clinical trials of the therapy or standard of care treatment...Hospitals and clinicians would track certain clinical data elements at baseline, at treatment, and then at three-month, six-month, one-year and two-year follow ups following administration...

The Food and Drug Administration has announced new measures to strengthen its regulation and oversight of dietary supplements, which have not been reviewed by the regulator...FDA Commissioner Scott Gottlieb said: “It’s clear that the US Food and Drug Administration plays an important role in helping consumers make use of safe, high-quality dietary supplements while also protecting Americans from the potential dangers of products that don’t meet the agency’s standards for marketing...the FDA is committing to new priorities when it comes to our oversight of dietary supplements at the same time that we carefully evaluate what more we can do to meet the challenge of effectively overseeing the dietary supplement market while still preserving the balance struck by Dietary Supplement Health and Education Act...the FDA posted 12 warning letters and five online advisory letters to US and international companies, which are illegally selling more than 58 products, primarily dietary supplements, as treatments for serious health conditions, such as Alzheimer’s disease, when their safety and efficacy is unknown...The companies contacted include Nutrition Coalition, TEK Naturals, Sovereign Laboratories and DK Vitamins...

A week after the Trump administration proposed ending drug rebates in federal health programs—and then urged Congress to extend that plan to commercial insurance—supply chain players are hitting back. The pharmacy benefit manager industry has even launched an ad campaign...But drugmakers are a different story. Eli Lilly CEO David Ricks said...that the proposal could “be a win for patients, lowering their out-of-pocket costs at the pharmacy counter," and inspire pharma to do more to demonstrate the value of their products...nixing rebates would “remove an artificial barrier to competition, creating space for innovation that addresses unmet needs for patients," Ricks said...

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

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...

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...