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Norman Sharpless, director of the National Cancer Institute in Bethesda, Maryland, will become acting administrator of the U.S. Food and Drug Administration...after current FDA chief Scott Gottlieb steps down in early April...The highly regarded Gottlieb reportedly recommended Sharpless as his replacement. He tweeted today: “I’m delighted by the announcement from @SecAzar that @NCIDirector will serve as acting commissioner of #FDA. Ned is a friend to FDA, a great public health champion, a dedicated physician, and will be warmly welcomed into his new role. FDA will benefit greatly from his leadership.”...READ MORE

Endo International Plc said...the U.S. health regulator has decided...not to include blood pressure treatment vasopressin in its list of drugs that can be used in compounding, in a boost to the drugmaker that makes the only FDA-approved version of the product...The company had sued the Food and Drug Administration in October 2017, alleging that the agency had improperly authorized the bulk compounding of hundreds of drugs, including “essentially a copy” of Endo’s Vasostrict...The agency’s decision renders the sale of compounded products containing vasopressin unlawful, unless manufactured using an FDA-approved product, Endo said...READ MORE

FDA inspections of generic drug plants are on the rise and should continue to increase through 2019...But the game has changed...with the number of pre-approval inspections growing more than surveillance inspections, in part to approve more generics in an effort to lower drug prices. This move to “risk-based” inspections...is expected to be more effective in a growing global manufacturing industry the FDA must oversee with limited resources...

Insulin drugmakers face new criticism for their pricing and use of patents on diabetes treatments, as two reports...shined a light on the pharma companies' business practices...Congressional Diabetes Caucus co-chairs attacked the current system as "unfairly putting insulin out of reach, placing millions of lives at risk." Their report makes 11 policy recommendations for Congress, ranging from encouraging value-based contracts to requiring more disclosure on rebates and list prices to addressing patent extensions...The Initiative for Medicine, Access and Knowledge...unveiled an analysis of the patents protecting Sanofi's top-selling diabetes treatment Lantus, finding nearly all of patent applications for the drug were filed by the French pharma after it was approved...These have extended Lantus' patent protection to 2031…

Scott Gottlieb has submitted his resignation as commissioner of the Food and Drug Administration, after nearly two years at the helm of the agency. Gottlieb plans to leave next month...The unexpected exit has created a number of uncertainties for the pharmaceutical industry. More clarity should come in the lead up to the leadership change. In the meantime, here are five key takeaways from Gottlieb's departure and time at the FDA...READ MORE

1. Who will be Gottlieb's successor?
2. Why is he leaving the FDA?
3. What work does Gottlieb leave unfinished?
4. How will the industry react to Gottlieb's departure?
5. What will Gottlieb's legacy be?

...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

The Food and Drug Administration is looking for "pathways" to legalize the sale of CBD oil and other cannabis-based compounds in food and beverages in a move that could remove one of the last remaining legal hurdles for companies hoping to sell such products across state lines...FDA Commissioner Scott Gottlieb outlined steps the agency is considering in regulating cannabis products after President Donald Trump signed the farm bill into law on Thursday. The legislation — an $867 billion, five-year spending bill that funds agricultural, nutrition and other federal programs — also loosened some federal restrictions on cannabis. It legalized hemp by removing it from the Controlled Substances Act while preserving the FDA's authority to regulate the products...

Scott Gottlieb took over as head of the Food and Drug Administration with a somewhat unconventional agenda...He quickly won over skeptics...And while the agency's core missions of drug and food safety remain unchanged, Gottlieb was able to elevate different, specific issues into the limelight...e-cigarettes, opioids and drug prices gave the agency new focus at the highest level...Gottlieb's willingness to call out drugmakers for what he memorably dubbed "shenanigans" and "Kabuki drug pricing" pushed the industry in a more public manner than past agency chiefs...Under his leadership, the FDA flagged anti-competitive concerns including drugmaker abuse of the REMS system and citizen petitions, as well as publishing a list of off-patent drugs with no generic competition...READ MORE

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...

Today we’re updating some of our proposed policies related to these outsourcing facilities. Among our goals is to make it more feasible for compounding pharmacies to become outsourcing facilities...ottlieb said the FDA’s aim for this guidance is to recognize the differences in drug production between outsourcing facilities and conventional drug manufacturers. The guidance is intended to provide clarity on quality assurance, maintaining suitable facilities, sterility, stability testing, and beyond-use or expiration dates for products that don’t go through the FDA drug approval process...This revised draft guidance includes...revisions related to release testing, stability testing and beyond-use dating, as well as policies that differentiate between the production of sterile and non-sterile drug products...