Lawmakers push for speedy approvals of ‘breakthrough’ drugs

Posted under Blog, Companies, congress, Diagnostics, Drug approvals, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

New legislative initiatives aimed at speeding U.S. drug approvals are all the rage in Congress these days. Pharmalot has the story of a new proposal from a bipartisan group of lawmakers calling for accelerated approval paths for "breakthrough" drugs. A breakthrough, they explain, would be a new treatment that has preliminary clinical evidence that it can do a better job at treating a serious or life-threatening ailment than existing meds. "Time and again we've seen regulators in Washington fail to keep up with the industries they are tasked to oversee," says Sen. Orrin Hatch (R-UT), a sponsor. "This bipartisan bill ensures that when it comes to treating patients suffering with cancer or other devastating illnesses, science and patient care will not be slowed down by government red tape." Story

Senator launches campaign for speedier approvals of targeted drugs

Posted under Blog, Companies, congress, Diagnostics, Drug approvals, Funding, Kay Hagan, Medical Devices, Medical Supply, PDUFA, Pharmaceuticals, Startups, Universities, Videos by Ryan McBride

In an already politically charged year for the FDA, U.S. Senator Kay Hagan is spearheading legislation that would expedite reviews and approvals of drugs against serious medical conditions, her home state's North Carolina News Network reported.

The report says the legislation aims to give speedier reviews to drugs that deliver major benefits to patients, including targeted meds for patients with serious diseases and therapies that address underserved medical needs. The details of the North Carolina Democrat's plan were scant, and it's unclear exactly how quick she wants reviews to be. The FDA, of course, already has practices in place to speed new drugs to market if they offer superior benefits to patients, among other things.

“But for patients suffering today from some diseases for which there are no current treatments or for those patients who are clutching to the hope that a better treatment will be developed for their rare diseases, medical advances cannot come fast enough," said Hagan, as quoted by NCNN. She pointed to successful programs that sped new HIV treatments to patients in the 1990s to bolster her case.

Some lawmakers and biopharma backers have blasted the FDA for slowing the advance of innovative therapies to the market. FDA boss Margaret Hamburg has answered critics by emphasizing the agency hit a 7-year high in approvals last year, so the regulator can indeed act quickly to green light drugs when warranted. Take its recent speedy approval of Vertex's ($VRTX) cystic fibrosis drug Kalydeco, which the agency blessed last month ahead of schedule. Still, agency brass will need to gain support from U.S. lawmakers to reauthorize PDUFA this year, making 2012 a good time for members of Congress to voice their hopes and concerns about how the FDA conducts business.

- check out Hagan's release
- here’s the report from NCNN

Special Report: FDA approvals of 2011

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Spike in approvals can't quell industry protests about the FDA

Increased U.S. aid, rare disease focus drives surge in drug approvals

Posted under Blog, Companies, Diagnostics, Drug approvals, Funding, Medical Devices, Medical Supply, Pharmaceuticals, rare diseases, Startups, Universities, Videos by John Carroll

Over the past 5 years the U.S. government has significantly ratcheted up the amount of money it devotes to developers in an effort to find new vaccines and antibiotics. "We have pushed the envelope more toward diminishing the risk for companies so that they'll be more interested in getting involved with us and developing things like vaccines and antivirals," Dr. Anthony Fauci, the NIH's infectious diseases chief, tells The Associated Press. And the increased focus on new drugs for rare diseases helped drive a spike in new drug approvals last year. A record 11 of 30 new drug approvals were for treatments for rare diseases. Story

Spike in approvals can’t quell industry protests about the FDA

Posted under Blog, Companies, Diagnostics, Drug approvals, FDA approval, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Throughout 2011 you could hear a growing chorus in the biopharma industry complain bitterly about the tougher regulatory challenges facing drug developers. Antibiotics got tougher. Diabetes got tougher. Obesity was always a tough nut to crack, and there were three biotechs this year that showed just how hard it can be.

The FDA responded. Throughout the course of the year top regulators at the agency like Janet Woodcock periodically defended the agency, pointing to new studies showing that the FDA was faster than the Europeans when it came to drug reviews. By the middle of the year, regulators started to point to a growing number of approvals, promising a likely spike in new drugs headed to the market this year.

By November the FDA had 35 approvals to boast about--with 24 coming ahead of any OKs in other countries. The agency publicly noted that 2011's approval rate will go down as one of the best years in the past decade after years of anemic approval rates.

Interestingly, I don't know of anyone in the industry who thinks the spike in approvals this year represents a major change. Most industry execs I talk with just don't believe we've turned the corner on productivity. And they may well be right. Smart developers at companies like Bristol-Myers Squibb ($BMY) and Roche may have proven their R&D and regulatory teams know how to deliver the goods, but with the industry undergoing an unfinished revolution on the development front, next year could see a drop in approvals. And if that happens, the FDA will be under even more pressure to work more closely with the industry on elaborating just how developers can stack the odds in their favor.

Related Articles:
Report: Senate staffers hammering out accelerated drug approval pathway
FDA boasts of 35 drug approvals in past year amid criticisms
FDA's Woodcock: What to expect in the next 25 years of medicine