Senate Appropriations Committee Funds FDA at Level Requested by President
The Senate Appropriations Committee voted July 15 to approve FDA funding at the President’s requested level, to the dismay of certain stakeholders who had hoped that the agency would be funded at the same level as that recently afforded by the House. The funding includes an additional $2 million for the Office of Generic Drugs and an offset of $5 million, to be determined by the Commissioner. The Committee also expressed its general support for generic drug user fees, for an electronic drug pedigree system that would track drugs as they move through the supply chain, and for guidance from the agency on limiting antibiotics in animal feed.

Mandatory Recall Authority Bill Introduced in Congress
Representative Edolphus Towns has introduced a bill that would give the FDA mandatory recall authority for drugs posing a risk to human health. The bill would permit the agency to order that distribution of a drug stop immediately and be the subject of a recall where the drug posed a risk of serious harm to humans or animals

FDA Withdraws Rule on Pediatric Medical Device Information
The FDA has announced that it has withdrawn a direct final rule that would have required the submission of readily available pediatric medical device information as a part of premarket approval applications, requests for humanitarian use device exemptions, and any product development protocols. The agency decided to withdraw the rule due to significant adverse comment received. More information is available at here.

Mark Mansour is a partner in the firm, Bryan Cave, LLP



House Committee Votes to Increase FDA Funding
A House Appropriations subcommittee has voted to increase the FDA’s budget by $55 million over the President’s request. The panel passed by unanimous consent the first proposed FDA spending bill for the 2011 fiscal year, funding the agency at $2.57 billion.

Administration Releases Plan Requiring Reporting of Counterfeit Products
The Obama administration has released a plan requiring device makers to report counterfeit products and to submit lists of their products to the FDA twice a year so the agency can better track legitimately marketed devices.

FDA Seeks Comments on Recordkeeping Requirements for Medical Devices
The FDA is seeking comments from the public regarding recordkeeping requirements related to the medical devices current good manufacturing practice quality system regulation. Comments are due by August 23, 2010. More information is available here.

FDA Issues Notice of Termination of EUAs for Certain in vitro Diagnostic Devices
The FDA has issued a notice of the termination of the declarations of emergency justifying Emergency Use Authorizations (EUAs) of certain in vitro diagnostic devices, personal respiratory protection devices, and antiviral products that were issued in response to the public health emergency involving 2009 H1N1 Influenza.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

FDA: Genetic Testing Kits are Medical Devices

The FDA has sent letters to five manufacturers of genetic testing kits stating that the agency is considering the kits to be medical devices. As such, the agency has said that they need to receive approval from the agency before they can be marketed. The House Energy and Commerce Committee has announced that it too is looking into the tests.

FDA Requests Notifications of Intention to Participate in Meetings on PDUFA Reauthorization

The FDA has issued a notice requesting that public stakeholders notify the agency of their intent to participate in periodic consultation meetings on reauthorization of the Prescription Drug User Fee Act (PDUFA). After the statutory authority for PDUFA expires in September 2012, the FDA will consult stakeholders to develop recommendations for the next PDUFA program. Notifications of intention to participate must be submitted by June 25, 2010. The first stakeholder meeting will be held on July 1, 2010, from 9 a.m. to 11 a.m. More information is available here.

FDA Corrects Dental Device Final Rule

The FDA has issued a notice that it is correcting an error in its Final Rule on dental devices, published on August 4, 2009. More information is available here.

FDA Seeks Comments on Labeling Requirements, Premarket Approval, Drug Co-Development

The FDA is seeking comments on the standardized format and content requirements for the labeling of over-the-counter (OTC) drug products. Comments are due by August 2, 2010. More information is available here.  The FDA is seeking comments on requirements for premarket approval of medical devices. Comments are due by August 9, 2010. More information is available here. The FDA also seeks comments on methods to co-develop two or more distinct investigational drugs intended to be used in combination to treat a disease or condition. FDA is planning to develop guidance for industry and other affected parties on the co-development of two or more novel drugs intended to be used in combination (but not as not fixed-dose combinations) and is seeking public input to identify the affected parties’ information needs concerning such co-development. Comments are due by September 7, 2010. More information is available here.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

Court Says Patent Settlements May Violate Antitrust Laws

A federal appeals court in New York indicated that patent settlements reached by drug companies may violate antitrust laws when they include payments to rivals to delay the introduction of generic products. The Justice Department has previously asserted that those types of payments may be illegal and the FTC has called on courts to consider the merits of the patents at issue when determining whether such settlements should be valid. FTC Chairman Jonathan Leibowitz has stated that these settlements cost consumers $3.5 billion per year through higher drug prices.

House Committee: FDA Didn’t Pursue Leads on Heparin Contamination

Members of the House Energy and Commerce Committee have stated that they have concluded an investigation into the FDA’s handling of the contaminated heparin crisis and found that the FDA failed to pursue certain leads which could have uncovered those responsible.

Speakers at Conference Advise Companies Not to Wait for FDA Guidance to Use Social Media

Speakers at a recent FDLI annual conference encouraged companies not to wait until after the FDA issues guidance on the use of the internet and social media to use those mediums. They did recommend that companies use caution when using social media or developing certain websites, including not promoting specific products and monitoring the sites and postings regularly.

FDA Seeks Comments on Proposed Collections of Information

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of information on administrative procedures for the Clinical Laboratory Improvement Amendments of 1988 (CLIA) categorization. Comments on the collection of information are due July 6, 2010. More information is available here.

The FDA is also seeking comments on for research entitled “Experimental Study of Patient Information Prototypes.” This study is designed to determine, based on different prototype testing, whether consumers are able to comprehend serious warnings, directions for use, drug indications and uses, contraindications, and side effects in the material that is presented. Comments are due July 6, 2010. More information is available at here.

The FDA has also announced that it has submitted a proposed collection of information regarding requirements for submission of labeling for human prescription drugs and biologics in electronic format to the Office of Management and Budget (OMB) for review and clearance. Comments on the collection of information are due June 3, 2010. More information is available here.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

FDA Launches New Initiative to Measure Performance

The FDA announced the launch of its newest initiative, FDA-TRACK, this week. The initiative is designed to help measure the agency’s performance through using a series of quantifiable benchmarks that would give congressional appropriators a clear understanding of how well the FDA uses its money.

PREDICT Rollout Delayed Indefinitely

The nationwide rollout of the FDA’s PREDICT electronic ranking system, designed to help uncover adulterated and misbranded imports, has been delayed indefinitely, due primarily to issues relating to IT infrastructure.

FDA Issues Final Rule on Device Pre-Market Submissions

Under the FDA’s final rule published on March 31, pre-market approval applications, beginning in August, will be required to include additional data on pediatric patients who suffer from diseases or conditions treated by the sponsor’s device. The rule requires MA applications, humanitarian device exemption (HDE) applications and PMA supplements for new intended uses to include “readily available” information on any pediatric subpopulations that suffer from the disease or condition addressed by the sponsor’s device, as well as information on the number of pediatric patients who might be treated with the device.

FDA to Release UDI Database Proposed Rule

CDRH has indicated that it expects to release a proposed rule for a unique device identifier (UDI) database this summer and is aiming at having a final rule in place by April 2011. Once the final rule is out, manufacturers of Class III devices will have one year to comply.

FDA Announces New Process for Approval of Radiotherapy Equipment

The FDA has announced that it will strengthen its approval process for new radiotherapy equipment and will no longer allow new radiotherapy equipment to use the streamlined approval process, in an effort to reduce overdoses, underdoses and other errors in radiation therapy.

Mark Mansour is a partner in the firm, Bryan Cave, LLP