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FDA Plans Advertising Study on ‘Corrective’ TV AdsCDER advertising and promotion officials want to know how a television direct-to-consumer
corrective ad impacts consumer misperceptions about prescription drug product safety and efficacy. A new study under development
— “Experimental Study: Examination of Corrective Direct-to-Consumer (DTC) Television Advertising” —
aims to screen 19,000 respondents on “message exposure, similarity of original and corrective ads, and length of time
between exposure to original and corrective ad,” according to an agency notice. [READ MORE]
HHS Did Block CDRH Decision on Amalgam: Center Staffer2/23/2012
As suspected in the face of FDA’s refusal to comment, HHS did indeed block CDRH’s
still-undisclosed decision in December on the safety of mercury-based dental amalgams, according to an email exchange between
Tulsa, OK attorney James Love and CDRH Dental Products Advisory Panel executive secretary Michael
Adjodha. Love has a 2009 petition for reconsideration of CDRH’s Class II final rule on amalgam that is still pending at the Center. The department’s
interference is its second known intrusion in FDA science since the Plan B “morning after” contraceptive pill over-ride in December. [READ MORE]
Is Europe Moving to an FDA-like Regulatory Scheme?2/22/2012
Critics of FDA’s medical device review program may find it harder in the near future to compare the ease of marketing
devices in Europe with that in the U.S. in the wake of an ongoing device safety scare involving breast implants that is shaking
up surveillance of European-marketed devices. Across the pond, critics there say Europe’s weak medical device regulation
is partly to blame for allowing French company Poly Implant Prothese to make and market substandard silicone breast implants,
with some calling for more FDA-like regulatory policies. As recently as last week, U.S. lawmakers were questioning CDRH director Jeffrey Shuren
about difficulties with predictability and consistency in the Center’s regulatory model and pointing to concerns that
some U.S. device makers decide to [READ MORE]
‘Notable Progress’ in FDA Reception of Marketing e-Submissions2/20/2012
Progress is well underway in FDA’s ongoing transition to universal (and, ultimately, mandatory) acceptance of regulatory
submissions for advertising/promotional submissions in electronic format, although the process is currently more advanced
for submissions related to biologic products than for drugs. Details concerning the status of the agency’s electronic
submissions initiative were discussed at the 2012 Marketing Conference sponsored by the Drug Information Association (DIA)
2/1.
According to CDER Office of
Prescription Drug Promotion associate director Marci Kiester, the process of transitioning to electronic
submissions for regulatory materials may be said to have begun in 2008, with FDA’s acceptance of the electronic Common
Technical Document (eCTD) — an ICH standard for regulatory submissions now recognized not only by FDA but by counterpart
Canadian, Japanese, Swiss, and European regulatory authorities. Kiester noted that Module 1 of the eCTD pertaining to advertising/promotional
submissions has recently undergone some modification in order to make it more user-friendly for sponsors, and more useful
to [READ MORE]
Grotesque Lawlessness by FDA on CDRH WhistleblowersWARNING:
Use of this computer system, a requirement of your employment, constitutes surrender of your Constitutional rights under the
First, Fourth and Fifth Amendments … It hasn’t quite reached this stage yet, but in the DC federal court
case of Paul T. Hardy et al vs. Jeffrey Shuren et al, plaintiffs vividly and plausibly describe conditions of FDA employment where they contend that scenario
already applies in effect, if not in fact. Indeed, it seems to be the logical next step in the steady evolution of government
opacity: Silencing all employees about management abuses they observe. Since December 2010, the federal government’s
computer system warns all users not to expect privacy and that “At any time, and for any lawful
government purpose, the government may monitor, intercept, and search and seize any communication or data transiting or stored
on this information system.” No better example of this might
be the case of Hardy v. Jeffrey Shuren, surely not a federal court case title that Shuren volunteered for when he
strove so hard to be CDRH director. [READ MORE]
Bill Introduced to Transform FDA’s Internal Processes 02/16/2012 Sen. Kay Hagan (D-NC)
says she will introduce the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) act to expedite
development of and access to safe and effective treatments for patients with serious or life-threatening diseases, including
rare diseases. Hagan says the bill would ensure the best science and greater innovation in medical treatments with better
access to expertise while maintaining FDA’s high safety and effectiveness standards. The measure was praised by BIO
president Jim Greenwood and representatives of other advocacy groups. A legislation fact sheet supplied by Hagan says the measure would: [READ MORE]
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