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- issue draft guidance with recommendations on establishing active ingredient sameness.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

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...

Sanofi SA and Regeneron Pharmaceuticals Inc said...that they will slash the U.S. list price of their potent but expensive cholesterol fighter Praluent by 60 percent, as the drugmakers follow a similar move by rival Amgen Inc in hopes of increasing use of the drug...The new list price for Praluent will be $5,850 a year, matching the price Amgen set when it lowered the list of its competing drug, Repatha...Sanofi and Regeneron said they expect the lower-priced Praluent to be available for pharmacies to order in early March. They said the new price should improve patient access and result in lower out-of-pocket costs for U.S. consumers...

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.

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

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...

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

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.

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...

Many more Americans may be getting opioids for their pets, and veterinarians appear to be prescribing increasingly potent versions of these drugs to animals...The researchers examined data on opioid tablets and patches dispensed or prescribed by 134 veterinarians at an academic small-animal hospital in Philadelphia from 2007 to 2017. Over the decade, the amount of opioids used for creatures like rabbits, birds and reptiles surged 41 percent even though visits to the hospital increased by only 13 percent...