FDA Panel Meeting Set on Vancocin Bioequivalence Dispute(5/29/09) FDA has scheduled an 8/4 advisory committee meeting to discuss
bioequivalence recommendations for oral vancomycin hydrochloride capsule drug products, which presumably is intended to resolve
an ongoing dispute. In March, ViroPharma asked FDA to withdraw its 12/08 draft guidance on establishing bioequivalence for
generic copies of the company’s Vancocin (vancomycin HCl capsules). Read More
New ‘Golden Age for FDA’ Seen by Grossman(5/29/2008) A “new golden age for FDA” is seen in a new Web blog posting by Coalition for a Stronger FDA deputy executive director Steven Grossman. In the posting on his new Web site headlined Welcome to FDA, Dr. Hamburg,
Grossman says the new commissioner has “advantages that previous commissioners did not enjoy. Read More
Aventis Pays $96 Million on False Claims Charges(5/28/2009) Aventis has agreed to pay $96 million to settle federal allegations
that it violated the False Claims Act by misreporting drug prices in order to reduce Medicaid rebate payments. Read More
Self Magazine Report Questions Generics’ QualityGeneric drugs’ safety and efficacy are being thrown into question by a Self magazine year-long investigation into whether generics are equal to their brand-name counterparts. Armed with complaints
and expert opinions about therapeutic problems occurring after patients are switched from brand drugs to generic equivalents,
the report, “Are Generic Drugs a Bad Bargain?” pointed to one cause raising alarm — about 90% of generic
active ingredients are now made overseas where FDA’s inspectional oversight is challenged the most. Read More
1:17 pm
Sharfstein Investigates LASIK Patients’ Complaints(5/22/09) FDA acting commissioner Joshua Sharfstein told FDA
Webview 5/21 that he is looking into complaints of many LASIK (laser-assisted in situ keratomileusis) eye vision enhancement
surgery patients that the agency has failed to honor its commitments to investigate their complaints since 2006 that the technique
has unacceptable risks. Read More
Newspaper Exposes FDA Bush-era Dependency on Industry Lobbyists(5/21/2008) The extent of FDA management’s dependency on regulated industry
in assessing contentious scientific issues during the Bush administration may be indicated in a 5/17 Milwaukee Journal
Sentinel exposé based on CFSAN e-mails. According to the newspaper, more than 100 pages of documents obtained
under FOI show that the Center’s draft determination that suspected mutagen bisphenol A is safe in baby bottles and other food containers was based on the work of “chemical industry lobbyists
to examine bisphenol A’s risks, track legislation to ban it and even monitor press coverage.” Read More
Science Board Endorses Pathogen Detection as Highest Priority(5/20/2009) FDA’s Science Board 5/18 unanimously endorsed a report saying the agency’s
science projects that are of highest priority and are important to a number of its enters are those related to rapid pathogen
detection; to pathogen detection and elimination in manufacturing and in products; and to more rapid and efficient detection
of adverse events. Read More
3:54 pm
Senate Unanimously Confirms HamburgThe Senate 5/18 voted unanimously to confirm Margaret Hamburg as FDA commissioner. During a 5/7 Senate
Health, Education, Labor and Pensions hearing, the 54-year-old public health physician and bioterrorism expert outlined her top five priorities
if confirmed. (read more)
2:14 pm
510(k) Route to Market Under New Attack(5/18/2009) Two new pointers to the inadequacy of Sec. 510(k) to protect
public health and safety emerged recently in a New York Times exposé of vaginal sling toxicity
and new medical literature reporting elevated safety issues with new ophthalmic lasers. Both devices, substantially different
from the “predicate” devices they referenced in their “substantially equivalent” 510(k) submissions
to FDA, are now the subjects of liability or malpractice lawsuits. They add to a growing list of earlier examples of problems
with 510(k) reviews in CDRH that cited other devices and are currently under Congressional
scrutiny. One, ReGen Biologics’ Menaflex, is the focus of an internal FDA re-examination ordered
by acting commissioner Joshua Sharfstein. (read more)
8:08 am
Lupin Slapped with GMP Warning Letter(5/15/2009) Lupin is the latest Indian drug maker to find itself in FDA’s
crosshairs after being issued a Warning Letter this month over GMP problems documented during an 11/08 inspection at the firm’s
generic cephalosporin manufacturing facility in Mandideep, India. Fifteen procedural observations were noted on the FDA-483.
(read more)
10:15 am
GMP Warning Letters Reflect Bad Inspection Response(5/14/2009) A just-released Hogan & Hartson analysis of more than 25 good
manufacturing practices (GMP) Warning Letters issued by FDA in the last 12 months shows that almost all of them addressed
inadequacies in the company’s inspection response. “While there are a variety of acceptable ways to respond to
an inspection observation,” the analysis says, “we have seen many examples of inspection and Warning Letter responses
that fail to adequately address FDA’s concerns.” (read more)
10:09 am
Total Ban on Drug Company Gifts Sought(5/13/2009) An Archives of Internal Medicine 5/11
editorial calls for a total ban on all drug company gifts and drug
samples to doctors. Northwestern University’s Philip Greenland says he believes that the evidence is solid that drug
company promotional activities are designed to influence and bias the physician-patient interaction and that the adverse effects
are achieved as a consequence of the interactions between doctors and drug marketing personnel. (read more)
Reps Want Menaflex Device Approval Reexamined(5/11/2009) Three Democratic leaders of the House Energy and Commerce Committee
have asked FDA to reexamine the 12/08 CDRH approval of ReGen Biologics’ Menaflex collagen scaffold that is used to reinforce
and repair the meniscus. The request is in a 5/11 letter from Energy and Commerce Committee chairman Henry Waxman (D-CA), Oversight and
Investigations Subcommittee chairman Bart Stupak (D-MI), and Health Subcommittee chairman Frank Pallone (D-NJ) to FDA acting
commissioner Joshua Sharfstein. (read more)
9:04 am
Obama’s FDA Proposed Budget Sets Record: Up 19%(5/8/2009) President Obama has proposed the largest budget increase ever for
FDA — an almost $511 million (19%) jump over the current FDA budget. In FY 2010 budget documents released 5/7, the administration’s overall request for FDA sits at
$3.2 billion and includes increases of $295.2 million in budget authority and $215.4 million in industry user fees to bolster
food and medical product safety. Half of the increase ($259 million) will go directly to food safety, HHS secretary Kathleen
Sebelius said during an afternoon press conference. (read more)
11:42 am
Synthes Settles NJ Conflict-of-Interest Suit (5/7/2009) Medical device maker Synthes has signed a settlement agreement with
New Jersey attorney general Anne Milgram to resolve allegations that the company failed to disclose financial conflicts-of-interest
among doctors conducting clinical testing on its products. Milgram says that FDA approved the company’s PMA without
picking up any of the financial conflicts and demanding more information. (read more)
8:59 am
Two Preemption Cases Back to District Court (5/5/2009) The Third Circuit Court of Appeals has sent two drug preemption
cases back to district courts for further proceedings in light of the Supreme Court’s ruling in Wyeth v. Levine.
(read more)
Public Perception of FDA Improves (5/1/2009) FDA’s reputation with the general public has improved in the
last year, according to a new Harris Interactive/HealthDay poll that
compares this year’s responses with those from a similar 2008 poll. (read more)
9:16 am
Hamburg Faces Senate Confirmation 5/7FDA commissioner-nominee Margaret Hamburg is scheduled to appear before the Senate
Health, Education, Labor and Pensions committee 5/7 for her confirmation hearing. (read more)
9:13 am
CDER’s Autor Predicts Increased and Swift EnforcementCDER enforcement actions will continue to rise in the foreseeable future, warned
Center Office of Compliance director Deborah Autor in Washington, DC 4/23. (read more)
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