May
21
Posted under
Biologics,
biosimilars,
Blog,
Companies,
Diagnostics,
FDA,
Funding,
Medical Devices,
Medical Supply,
PDUFA,
Pharmaceuticals,
Regulatory,
Startups,
Universities,
user fee legislation,
Videos by John Carroll
Bipartisanship is a rare sight in Congress these days, but a top tier of politicos in Washington D.C. says they've managed to hit the sweet spot with new user fee legislation being taken up by the Senate this week. That note of harmony is likely to sing the bill through to passage, triggering promises of significant improvements related to FDA access and cooperation in drug and device development.
As noted by Bloomberg today, the PDUFA reauthorization bill of 2012 calls for a 6% bump in fees from drugmakers. There's also a $1.5 billion contribution from generic drugmakers in exchange for a commitment to shorten the prolonged review times--30 months on average--generics face at the regulatory agency. Devicemakers are doubling down on their fees, looking for easier access to regulators as they plot development programs. And for the first time there's a new source of fee income that will flow from the fledgling biosimilars industry, which is developing the first generation of biologic copies.
The biopharma industry has been hammering away at the FDA for months now, accusing the agency of dragging their feet on drug reviews or blindsiding them with unexpected challenges. Under PDUFA 2012 regulators promise to commit to offering more meetings and advice on trial designs with an eye to speeding the approval process.
"Drug developers feel there really is value in getting FDA's perspective early to avoid surprises in an application review," Catalyst Healthcare Consulting President Nancy Bradish Myers tells Bloomberg. By getting more access early on, drugmakers believe they can improve the odds of an initial approval, without having to go back to the drawing board to gather more data.
Dig down into the legislation, and you'll also find a commitment to speed approvals for new drugs that address serious or life-threatening diseases, offering a willingness to use surrogate endpoints to extend approvals rather than waiting for data on some of the gold standard endpoints that have been in place for years.
It's unlikely, though, that the legislation's commitment to greater transparency and efficiency at the agency will translate into broad happiness in the industry with the FDA. Hurt by the steadily rising sums spent on drug development and frequently stung by caustic regulatory reviews, the industry is always likely to have a wary take on regulatory reviews and cooperation. And faced with a history of safety issues related to new drugs, the FDA is likely to continue to remain skeptical when it hears industry criticism.
- here's the story from Bloomberg
Related Articles:
Conflict threatens as FDA user-fee bills near a vote
Pharma defeats biotech push for rapid approval program
Study: FDA outpaces the EMA on drug reviews, new approvals
Hope runs high that FDA user fee bill will escape congressional acrimony
May
17
Posted under
Blog,
Companies,
Diagnostics,
FDA,
Funding,
Kathleen Stratton,
Medical Devices,
Medical Supply,
PDUFA,
Pew Charitable Trusts,
Pharmaceuticals,
Regulatory,
Startups,
Universities,
Videos by John Carroll
After cranking up as much pressure as the industry could muster over the last year, lawmakers have been queuing up new laws aimed at speeding the FDA's review of drugs while gaining fresh pledges from regulators on flexibility and swifter decision-making. But a new study published in The New England Journal of Medicine concludes that an objective look at the data scuttles the whole notion that regulators in the U.S. are too slow when it comes to saying yes to a new therapy.
Investigators looked at every approval handed out for a new chemical entity between 2001 and 2010. They found that FDA regulators were on average 15% faster than either the EMA or Health Canada. Of the 225 drug applications studied, the average review time hit 322 days at the FDA. And the U.S. agency was the first to approve two of every three new drugs filed with both the FDA and the EMA.
"This allows us to focus on the important question of whether there are real barriers to drug innovation in the U.S.," Kathleen Stratton of the Pew Charitable Trusts told the AP. "But it's clear from this study that the speed at which the FDA reviews drug applications is not one of them." Pew, a noted advocate for public safety, funded the study undertaken by investigators at Yale and the Mayo Clinic.
It's unlikely that many executives in the biopharma industry would agree with that remark. Negotiations over the new PDUFA law includes pledges of speedier reviews and more predictable responses. That came after a long and intense campaign in which industry leaders moaned about the risky and enormously expensive drug development process. And some might argue that just because U.S. regulators are faster than colleagues in Europe and Canada, that doesn't make them as fast as they should be.
One other point: The review was limited to approved drugs, excluding the time involved for drugs that were ultimately red-flagged by the agency.
- here's the AP report
Related Articles:
Regulators start thinking creatively about new approval pathway
Conflict threatens as FDA user-fee bills near a vote
Spike in approvals can't quell industry protests about the FDA
FDA combats criticisms over speed with ESRD pathway
May
09
Posted under
2012 BIO International Convention,
biosimilars,
biotech regulation,
Blog,
Companies,
Diagnostics,
Events,
FDA,
Food and Drug Administration,
Funding,
Medical Devices,
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PDUFA,
Pharmaceuticals,
regulation,
Startups,
Universities,
Videos by biotechnow@bio.org (Biotechnology Industry Organization)
In the words of BIO’s Andrew Emmett, Managing Director, Science & Regulatory Affairs, ‘2012 is shaping up to be a momentous year for FDA reform.’ From the reauthorization of the Prescription Drug User Fee Act (PDUFA V) to modernizing and expediting the approval of new drugs and biologics, implementing the new biosimilars pathways and addressing the growing global drug shortage crisis, all eyes are on the current regulatory environment and its role in supporting innovation.
The 2012 BIO International Convention will return to Boston, MA and the Boston Convention and Exhibition Center, June 18-21, 2012 and will feature a breakout session track on regulatory issues.
Attendees can expect the Achieving Regulatory Approval and Compliance educational track to feature leading Food & Drug Administration (FDA) leaders who will share their prospective priorities, senior European medical agency executives discussing international and harmonization issues as well as major biotechnology and pharmaceutical companies exploring best practices and addressing questions.
With drug development a long and costly process, speakers will also address how companies can continue to innovate and attract investor capital.
Highlights include:
FDA Town Hall
Tuesday, June 19, 2:00 p.m. – 3:30 p.m.
Speakers: Karen Midthun, MD, Director, Center for Biologics Evaluation and Research, Food and Drug Administration (FDA) and Janet Woodcock, Center for Drug Evaluation and Research, Food and Drug Administration (FDA)
PDUFA V: Impact on Innovation, Patients, and Modern Medicines – Super Session
Wednesday, June 20, 3:30 p.m. – 5:15 p.m.
Moderator: Steve Usdin, Washington Editor, BioCentury, Co-host, BioCentury This Week
Speakers: Marc Boutin, JD, Executive Vice President and Chief Operating Officer, National Health Council, Peter Greenleaf, President, MedImmune, and Margaret Hamburg, M.D., Commissioner of Food and Drug Administration (FDA)
Analysis and Impact of PDUFA V: What Regulatory Affairs Professionals Need to Know
Tuesday, June 19, 8:30 a.m. – 9:45 a.m.
Moderator: Janet Jenkins-Showalter, Senior Regulatory Group Director, Genzyme, A Member of the Roche Group
Speakers: Andrew Emmett, Managing Director, Science and Regulatory Affairs, Biotechnology Industry Organization, Kay Holcombe, Senior Policy Advisor, Genzyme, a Sanofi Company, and Patrick Frey, Director, Office of Planning and Analysis, Center for Drug Evaluation and Research (CDER), Food and Drug Administration
Interchangeable Biosimilars: Distinguishing between Aspiration and Achievement
Thursday, June 21, 8:30 a.m. – 9:45 a.m.
Moderator: Ramsey Baghdadi, Senior Editor, The RPM Report
Speakers: Erika Lietzan, Special Counsel, Covington & Burling LLP, Joseph Miletich, Senior Vice President, Research and Development, Amgen, Gregory Schimizzi, Co-Founder, Carolina Arthritis, Coalition of State Rheumatology Organizations and Jan Wyatt, Patient Advocate, Arthritis Foundation
Biological Product Pediatric Development in the US: Implementation of PREA and BPCIA
Monday, June 18, 3:45 p.m. – 5:00 p.m.
Moderator: Chin Koerner, Executive Director, Novartis Pharmaceuticals
Speakers: Barbara Buch, MD, Supervisory Medical Officer, Center for Biologics and Evaluation Research, Food and Drug Administration (FDA), Sharon Olmstead, Vice President, Novartis Pharmaceuticals and Karen Weiss, Vice President, Janssen Research and Development
To learn more about the Achieving Regulatory Approval and Compliance educational track and get the most up-to-date program and speaker information, visit http://convention.bio.org/program/.
Feb
17
Posted under
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Companies,
congress,
Diagnostics,
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Kay Hagan,
Medical Devices,
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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
Related Articles:
Increased U.S. aid, rare disease focus drives surge in drug approvals
Spike in approvals can't quell industry protests about the FDA