Life Sciences Legal Update

CMS Announces Data Collection for the Physician Payments Sunshine Act Will Not Be Required Before 2013

Lisa Baird — Fri, 04 May 2012 15:34:52 -0500

The Centers for Medicare & Medicaid Services (CMS), tasked with implementing the Physician Payments Sunshine Act, announced yesterday that it will not require pharmaceutical, device, and other applicable manufacturers and group purchasing organizations (GPOs) to begin collecting reportable data before 2013. Once implemented, the Physician Payments Sunshine Act (Section 6002 of the Affordable Care Act) will require manufacturers and GPOs to report information regarding payments to physicians and physician ownership and investment interests.

To learn more about this development regarding the Physician Payments Sunshine Act, please see the full post written by Elizabeth B. Carder-Thompson, Katie C. Pawlitz, Nancy E. Bonifant and Debra A. McCurdy on Reed Smith’s Health Industry Washington Watch blog.

Update: New Hampshire State Senate Hearing on Prohibition of Certain Physician Relationships with Medical Device Companies

Lisa Baird — Thu, 03 May 2012 16:41:13 -0500

This post was written by Elizabeth Carder-Thompson and Nancy E. Bonifant.

The New Hampshire State Senate held a hearing on April 19, 2012 regarding HB 1725, a new measure that would prohibit all health care practitioners from prescribing or referring any U.S. Food and Drug Administration class II or class III implantable medical device if the practitioner stands to “profit indirectly or directly from the sale of [the] medical device by any supplier in which the health care practitioner has a direct or indirect ownership interest.” The testimony from supporters and opponents at the hearing, as well as recent commentary on the bill, indicate that there is significant disagreement over the reach of the measure and in particular whether the definition of “ownership interest” will include “royalty arrangements” between practitioners and medical device manufacturers.

As currently drafted, HB 1725 incorporates the following broad definition of “ownership interest”:

Any and all ownership interest by a healthcare practitioner or such person’s spouse or child, including, but not limited to, any membership, proprietary interest, stock interest, partnership interest, co-ownership in any form, or any profit-sharing arrangement. It shall not include ownership of investment securities purchased by the practitioner on terms available to the general public and which are publicly traded.

At the hearing, supporters of the bill clearly stated that the bill’s purpose is to address growing concerns regarding physician-owned distributors (“PODs”), which can implicate state and federal anti-kickback prohibitions. Opponents, however, argued that the current definition of “ownership interest” could reach much further. On the one hand, “royalty arrangements” between practitioners and medical device manufacturers could arguably be deemed “compensation arrangements” involving the transfer of intellectual property rather than “ownership interests,” and hence fall outside of the bill’s proscriptions. At the same time, the broad definition in the proposed legislation of “any and all ownership interests” followed by a non-exclusive list of examples, and the current significant disagreement over the measure’s reach, suggest that the bill would benefit from additional drafting for clarity.

We will continue to monitor developments in this area. To view our previous post on this topic, click here.

Small Cardiology Practice to Pay $100,000 to Settle Allegations of HIPAA Violations

Lisa Baird — Fri, 20 Apr 2012 13:34:32 -0500

This post was written by Nancy E. Bonifant and Brad M. Rostolsky.

On April 17, 2012, the HHS Office of Civil Rights (OCR) announced a settlement and corrective action plan with Phoenix Cardiac Surgery, P.C. (Phoenix), a small cardiology practice based in Phoenix and Prescott, Arizona. More specifically, Phoenix has agreed to pay $100,000 to settle allegations of HIPAA violations arising out of an investigation conducted by OCR.

OCR’s investigation of Phoenix followed a report that Phoenix was posting clinical and surgical appointments for its patients on an Internet-based calendar that was publicly accessible. On further investigation, OCR discovered the following issues:

Phoenix failed to implement adequate policies and procedures to appropriately safeguard patient information;
Phoenix failed to document that it trained any employees on its policies and procedures on the Privacy and Security Rules;
Phoenix failed to identify a security official and conduct a risk analysis; and
Phoenix failed to obtain business associate agreements with Internet-based email and calendar services where the provision of the service included storage of and access to its electronic protected health information.

This settlement serves as additional evidence of OCR’s increased focus on enforcement actions for alleged HIPAA violations, following just one month after the first enforcement action resulting from a breach self-report under the Breach Notification Rule. According to Leon Rodriguez, Director of OCR, he “hope[s] that health care providers pay careful attention to this resolution agreement and understand that the HIPAA Privacy and Security Rules have been in place for many years, and OCR expects full compliance no matter the size of a covered entity.” Additionally, the settlement provides further evidence that OCR will likely view any investigation of an alleged Privacy or Security Rule infraction as an opportunity to conduct a de facto audit of the entity’s general compliance with HIPAA.

In addition to the $100,000 settlement, the Resolution Agreement between Phoenix and OCR requires Phoenix to develop and maintain written Privacy and Security policies, which will set forth, at a minimum, administrative safeguards, technical safeguards, and training of all Phoenix’s workforce members. In addition, Phoenix will provide specific training on the Privacy and Security policies within 60 days of OCR’s approval to all workforce members who use or disclose protected health information and will report any violations of those policies and procedures by a workforce member to OCR within 30 days. Phoenix did not admit any liability in the agreement and OCR did not concede that Phoenix was not liable for civil monetary penalties.

Additional information about OCR’s enforcement activities can be found at http://www.hhs.gov/ocr/privacy/hipaa/enforcement/examples/index.html.

New HHS Federal Research Conflict of Interests Regulations

Lisa Baird — Thu, 19 Apr 2012 15:24:26 -0500

On September 26, 2011, the U.S. Department of Health and Human Services ("HHS") issued new regulations governing the disclosure by faculty members and research staff of significant financial interests related to certain federal grants, and the reporting of "financial conflicts of interest" to certain federal agencies by colleges and universities that receive funding for Public Health Service ("PHS")-sponsored research. See 42 C.F.R. § 50.601 et seq.

The new regulations significantly expand the coverage of 1995 HHS regulations on the same subject. Colleges and universities that receive research funding from a PHS "Awarding Component," including the National Institutes of Health ("NIH"), must be in compliance with the new regulations by no later than August 24, 2012.

To learn more, read the full alert written by Lane Kneedler and Pakapon Phinyowattanachip available on Reed Smith's Global Regulatory Enforcement Law Blog.

New Hampshire Quietly Considers Prohibition Of Physician Relationships With Medical Device Companies

Lisa Baird — Tue, 17 Apr 2012 16:52:30 -0500

This post was written by Elizabeth Carder-Thompson and Nancy E. Bonifant.

On March 29, 2012, the New Hampshire House of Representatives recommended for passage HB 1725. If passed, HB 1725 would prohibit all health care practitioners from prescribing or referring any U.S. Food and Drug Administration class II or class III implantable medical device if the practitioner stands to profit, directly or indirectly, from the sale of the device, or from performing any procedure involving the device.

Proponents of the bill assert that it is necessary to address growing concerns regarding physician-owned distributors (“PODs”). As drafted, however, the bill reaches much further than PODs by incorporating the definition of "ownership interest" from Sections 125:25-a to 125:25-c of the New Hampshire Revised Statutes, which requires practitioners to disclose to patients and licensing authorities “any and all ownership interests” the practitioner has in entities that provide diagnostic and therapeutic services. A relationship that triggers the disclosure requirements, therefore, is not limited to PODs. As a result, HB 1725 could prohibit legitimate intellectual property relationships between practitioners and medical device companies that exist to develop and promote life-saving medical devices. Thus, the bill could significantly affect a practitioner’s ability to continue practicing in his or her specialty in New Hampshire if that practitioner has an ownership interest in a medical device related to his or her practice.

In addition to constituting an unfair or deceptive act or practice in violation of New Hampshire law, failure to comply with the prohibition would expose practitioners to a $5,000 fine per procedure for a first offense and potential suspension or loss of professional licensure, and up to a $10,000 fine, for a second offense.

HB 1725 has been fast-tracked to the New Hampshire Senate, where it is expected to meet with approval. A hearing has been scheduled for this Thursday, April 19.

Life Sciences Health Industry China Briefing - March 2012 (April 13, 2012)

Lisa Baird — Mon, 16 Apr 2012 14:38:36 -0500

Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries. Some developments during March include:

American Medical Device Maker Accused of Bribery to Doctors in China and other Countries
Qiagen Inks HPV Screening Deal with China's KingMed Diagnostics
Medical Care Administration to Improve through Health Cards
Cuts in Drug Prices
Notice Concerning Registration after Adjustment of Classification of Medical Devices
MOH Encourages Private Capital into Medical Rehabilitation Services

To read the full briefing by Reed Smith China team members, click here.

10-Year 'Look Back' Proposed for Identification and Return of Medicare Part A and B Overpayments

Lisa Baird — Tue, 20 Mar 2012 14:30:31 -0500

This post was written by Scot T. Hasselman, Julia Krebs-Markrich, Thomas W. Greeson and Paul W. Pitts.

Providers and suppliers have until April 16, 2012 to comment on the proposed rule to implement provisions of Section 6402(a) of the Affordable Care Act that require “persons” receiving Medicare and Medicaid funds to report and return overpayments no later than 60 days after the date on which the overpayment was identified or, if applicable, the date any corresponding cost report is due.

The proposed rule, which is currently limited to Medicare Part A and B providers and suppliers, is important because it clarifies when and how an overpayment must be returned. If promulgated in final form as currently drafted, the rule would also subject providers and suppliers to a 10-year “look back” period, meaning providers and suppliers would have liability for the 10 years preceding the date an overpayment is received. The proposed rule has serious implications for provider and supplier operations if adopted as proposed. Providers and suppliers should consider using the public comment period to voice their concerns while it might still make a difference.

To learn more about the proposed rule and its implications, read the full alert.

FCA Qui Tam Relator Sanctioned for Destroying Evidence on Company-Issued Laptop

Lisa Baird — Fri, 16 Mar 2012 16:02:11 -0500

This post was written by Andrew Bernasconi and Nathan Fennessy.

In yet another reminder about the importance of maintaining evidence on company-issued laptops, blackberries, or other electronic devices; the United States District Court for the Northern District of California recently sanctioned a qui tam relator for destroying more than 10,000 documents on his company-issued laptop. Moore v. Gilead Sciences, Inc., No. C 07-03850 SI, 2012 WL 669531 (N.D. Cal. Feb. 29, 2012).

To read the full post on Reed Smith's Global Regulatory Enforcement Law Blog, click here.

OCR Announces First Enforcement Action Resulting From a Breach Self-Report

Lisa Baird — Thu, 15 Mar 2012 11:09:29 -0500

This post was written by Nancy E. Bonifant and Brad M. Rostolsky.

On March 13, 2012, the HHS Office of Civil Rights (OCR) announced the first enforcement action resulting from a breach self-report required by HITECH’s Breach Notification Rule. Blue Cross Blue Shield of Tennessee (BCBST) has agreed to pay HHS $1,500,000 to settle potential violations of the HIPAA Privacy and Security Rules and has entered into a corrective action plan to address gaps in its HIPAA compliance program.

The HIPAA/HITECH Breach Notification Rule requires covered entities to report a breach (e.g., an impermissible use or disclosure of protected health information that compromises the security or privacy of the protected health information) to the affected individual(s), HHS and, at times, the media. OCR’s investigation of BCBST followed a breach report submitted by BCBST informing HHS that 57 unencrypted computer hard drives were stolen from a leased facility in Tennessee. The hard drives contained the protected health information of more than 1 million individuals, including member names, social security numbers, diagnosis code, dates of birth, and health plan identification numbers.

According to OCR’s investigation, BCBST failed to implement appropriate administrative and physical safeguards as required by the HIPAA Security Rule. More specifically, BCBST failed to perform the required security evaluation in response to operational changes and did not have adequate facility access controls.

In addition to the $1,500,000 settlement, the Resolution Agreement between BCBST and OCR requires BCBST to revise its Privacy and Security policies, conduct robust trainings for all employees, and perform monitor reviews to ensure compliance with the corrective action plan. BCBST did not admit any liability in the agreement and OCR did not concede that BCBST was not liable for civil monetary penalties.

Additional information about OCR’s enforcement activities can be found at http://www.hhs.gov/ocr/privacy/hipaa/enforcement/examples/index.html.

Life Sciences Health Industry China Briefing - February 2012 (March 13, 2012)

Lisa Baird — Tue, 13 Mar 2012 15:30:14 -0500

This post was written by Jay J. Yan, Mao Rong, Zack Dong, Katherine Yang, Joyce Sun, Sara Lai and Gordon B. Schatz.

Some important developments during February include:

Release of the 12th Five-Year Plan on Drug Safety and Standards
SFDA: Concentrated Rectification Action in National Drug Manufacturing and Distribution Sectors
Twelve Ministries: Crackdown on Serious Illegal Advertisement Broadcasting
SFDA: Electronic Drug Supervision Plan from 2011 – 2015
MOH: Administrative Measures on Health Card for Residents (for Trial Implementation)
MOH: Revised Diseases Classification and Code

To read the full briefing by Reed Smith China team members, click here.

In-House Relator? The 2nd Circuit Considers Whether To Put the False Claims Act Between Attorneys and Their Clients

Lisa Baird — Wed, 29 Feb 2012 11:54:07 -0500

This post was written by Matthew R. Sheldon and Alexander Y. Thomas.

The Second Circuit Court of Appeals is reviewing a lower court decision disqualifying a former in-house attorney from acting as a False Claims Act qui tam relator against his former employer. The relator was formerly general counsel to Unilab, a subsidiary of Quest Diagnostics Inc. The qui tam suit alleged that Unilab violated the Federal Health Care Anti-Kickback Act by engaging in a fraudulent scheme to increase medical testing referrals under the Medicare and Medicaid programs. To read the full post on Reed Smith's Global Regulatory Enforcement Law Blog, click here.

Predictive Coding Receives Judicial Stamp of Approval

Lisa Baird — Wed, 29 Feb 2012 10:55:00 -0500

This post was written by David R. Cohen and Caitlin Gifford.

On Friday, February 24, New York Magistrate Judge Andrew Peck issued an opinion and order in Da Silva Moore v. Publicis Groupe & MSL Group, 11 Civ. 1279 (ALC) (AJP) (S.D.N.Y. Feb. 24, 2012), the first documented case to recognize predictive coding as an acceptable method of searching for electronically stored information ("ESI"). "Predictive coding," or computer-assisted review, is a process that can replace some human review with computer review, thereby reducing the cost of large-scale, e-discovery reviews. A typical technique is to identify a suitable "seed set" of documents that are reviewed by case attorneys and coded for relevancy, privilege, and other factors. Based on that coding, the system is trained to learn what is relevant and what is not; then the system itself predicts or suggests documents that are potentially relevant or similar across the document collection.

Click here to read the full alert prepared by Reed Smith's Records and E-Discovery Group.

Life Sciences Health Industry China Briefing - January 2012 (February 13, 2012)

Lisa Baird — Mon, 13 Feb 2012 18:50:02 -0500

This post was written by Jay J. Yan, Mao Rong, Zack Dong, Katherine Yang, Joyce Sun, Sara Lai and Gordon B. Schatz.

Some important developments during January include:

Outline of China's Nursing Development Plan from 2011 to 2015
Promulgation of Eight Recommended Medical Product Industry Standards
Strengthening Implementation of 2010 GMP Amendment
Circulation of the 12th Five-Year Plan for Medical Device Technology Industry

To read the full briefing by Reed Smith China team members, click here.

CMS Releases Long-Awaited Proposed Rule to Implement ACA Medicaid Manufacturer Rebate and Pharmacy Reimbursement Provisions

Tammy Thwaites — Tue, 31 Jan 2012 10:15:06 -0500

This post was written by Joseph W. Metro, Robert J. Hill, and Vicky G. Gormanly.

On Friday, January 27, 2012, the Centers for Medicare & Medicaid Services (“CMS”) released its long-awaited proposed rule to implement the provisions of the Affordable Care Act (“ACA”) relating to pharmaceutical manufacturer payment of Medicaid rebates and limits on Medicaid reimbursement to pharmacies. The proposed rule addresses a number of important policy issues relevant to pharmaceutical manufacturers, pharmacies, and other providers, and also would pose significant operational challenges for pharmaceutical manufacturers with respect to the Medicaid Drug Rebate Program (“MDRP”).

The official version of the proposed rule, titled “Medicaid Program; Covered Outpatient Drugs” (the “Proposed Rule”), will be published in the Federal Register on February 2, 2012. Comments on the Proposed Rule are due no later than 5:00 PM EST on April 2, 2012. Notably, the CMS Press Release indicates that CMS plans to issue a final rule in 2013.

We have identified below some of the key items addressed in the Proposed Rule on our sister blog, Reed Smith Health Industry Washington Watch, and we will be issuing a more detailed health care client bulletin in the near future.

Overview and Analysis of the Proposed Federal Sunshine Regulations

Lisa Baird — Fri, 27 Jan 2012 17:27:01 -0500

On December 19, 2011, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule (the “Proposed Rule”) related to section 6002 of the Affordable Care Act, commonly referred to as the “Physician Payment Sunshine Act.” The Physician Payment Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical supplies covered under Medicare, Medicaid, or CHIP to report annually to the Secretary of the Department of Health and Human Services (“Secretary”) certain payments or other transfers of value to physicians and teaching hospitals. Additionally, applicable manufacturers and applicable group purchasing organizations (“GPOs”) must report certain information regarding the ownership or investment interests in them that are held by physicians or their immediate family members.

To learn more about this development regarding the Physician Payment Sunshine Act, please see the full post written by Elizabeth B. Carder-Thompson, Katie C. Pawlitz, Nancy E. Bonifant and Debra A. McCurdy on Reed Smith’s Health Industry Washington Watch blog.

Life Sciences Health Industry China Briefing - December 2011 (January 12, 2012)

Lisa Baird — Thu, 12 Jan 2012 18:14:56 -0500

This post was written by Jay Yan, Mao Rong, Zack Dong, Gordon Schatz, and Katherine Yang.

Some important developments during December include:

SFDA Issues Catalogue of Class II Medical Devices Exempted from Submitting Clinical Trial Materials
SFDA Issues Notice Concerning Circulation of Guiding Principles of Phase I Clinical Trial Management of Drugs
SFDA Issues Notice on Soliciting Comments on Revisions of the Good Supply Practice for Pharmaceutical Products
China Adopts Drug Safety Plan: All Drugs to be Qualified by 2015
NDRC Issues Rules on Drug Price Parity to Prevent Disguised Price Hikes
Guangdong Issues Drug Price Adjustment Program: 307 Western Drugs’ Price have a 22 percent Reduction in Average
Shenzhen Public Hospitals to Revoke Drug Price Addition by the End of 2012

To read the full briefing by Reed Smith China team members, click here.

Health Care Companies Operating in France to be Subject to New Sunshine/Transparency Rules

Lisa Baird — Tue, 10 Jan 2012 14:47:19 -0500

This post was written by Marina Cousté, Benoît Charot, François Jonquères and Daniel Kadar.

Health care and cosmetic companies operating in France are subject to new transparency requirements, comparable to the U.S. "Sunshine Act," that were adopted in December 2011. As discussed in a recent posting on Reed Smith's Global Regulatory Enforcement Law Blog, in addition to imposing a general disclosure obligation on any company manufacturing or commercializing products with a medical or cosmetic purpose, the new law sets forth new pharmacovigilance requirements and provides more stringent rules concerning the advertisement of drugs and medical and diagnostics devices.

Life Sciences Health Industry China Briefing - November 2011 (December 6, 2011)

Lisa Baird — Tue, 06 Dec 2011 09:56:22 -0500

This post was written by Jay Yan, Mao Rong, Zack Dong, Zhao Hong, Gordon Schatz, Dr. David Kan and Katherine Yang.

Some important developments during November include:

Beijing Hospital Requirements: Overuse of Antibiotics
SFDA Issues Second Batch of Class II Medical Devices, For Which Distributors Do Not Need to Apply for Medical Devices Distribution License
Interim Measures on Appraisal of Traditional Chinese Medicine Hospitals: Request for Comments
Two Pharmaceutical Companies Fined for Monopolizing Compound Reserpine API
China to Build ADR Monitoring System
NDRC to Investigate Ex-factory Prices of Drugs
China Finalizes Healthcare Reform 12th FYP
China to Launch Massive Survey on TCM Resources
Notice Concerning Circulation of the 12th Five-year Plan of Biotechnology Development

To read the full briefing by Reed Smith China team members, click here.

Life Sciences Health Industry China Briefing

Lisa Baird — Tue, 22 Nov 2011 15:56:14 -0500

This post was written by Jay Yan, Mao Rong, Zack Dong, Zhao Hong, Gordon Schatz, Dr. David Kan and Katherine Yang.

Some important developments during October include:

SFDA Issues 2010 Annual Report on Drug Registration and Approval
CCTV to Restrict Advertisement of Alcohol, Medical Institutions
MOH Requires Improvement of the Reward and Penalty System for Antibacterial Drug Administration
Draft Mental Health Law Submitted to NPC Standing Committee for First Deliberation
SFDA: All Drugs on Market to Have E-ID by End of 2015
SFDA Releases 3rd Batch of Illegal Drugs, Medical Devices and Health Food Advertisements in 2011
SFDA issues Notice on Release and Delivery of GMP Certification Announcement
SFDA issues Notice concerning Circulation of the Administrative Measures on Drug Supervision in Medical Institutions
Detailed Summary of SFDA 2010 Annual Report on Drug Registration and Approval

To read the full briefing by Reed Smith China team members, click here.

Increased Scrutiny for the 510(k) Process

Lisa Baird — Thu, 17 Nov 2011 08:39:48 -0500

This post was written by Michelle Lyu Cheng.

On November 14, 2011, the Senate Health, Education, Labor and Pensions Committee held a hearing called "Medical Devices: Protecting Patients and Promoting Innovation." The hearing focused on the continued viability of a medical device clearance process that clears for market medical devices that are "substantially equivalent" devices to previously cleared devices (also known as the "510(k) process," in reference to the statutory provision governing this process). Class III medical devices not cleared through this process must undergo the more rigorous and time-consuming Premarket Approval process. Among the issues considered were whether the 510(k) process sufficiently evaluated the safety of devices when clinical data is not necessarily always considered or part of the submission; whether high-risk medical devices should always be considered for the 510(k) process; the user fees for medical device applications; strengthening post-approval monitoring requirements; and the resources and needs for the FDA and the Center of Devices and Radiological Health (CDRH) in reviewing, clearing and approving medical devices.

Testifying witnesses before the panel were as follows: Jeffrey Shuren, Director of the CDRH of the Food and Drug Administration; Ralph Hall, Professor of Practice, University of Minnesota, Minneapolis; David R. Challoner, M.D., Vice President (emeritus) of Health Affairs, University of Florida, and Chair, IOM Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, Gainesville, Fla.; and Gregory Curfman, M.D., Executive Editor, New England Journal of Medicine, Boston.

The first discussion panel centered on Dr. Shuren and his work with CDRH. In late 2009, the CDRH initiated a review of the 510(k) process, among others, and in 2010, released two reports concluding that the FDA had not managed its premarket programs sufficiently, with the most dire problem being unpredictability in the 510(k) and other premarket processes. This led to other increases in costs to the industry and delays in bringing innovation to the market. The root causes were determined to be the lack of personnel resources in CDRH, as compared with the center for drugs and biologics, insufficient reviewer training, insufficient managers and frontline reviewers, rapidly growing workload caused by increased complexity of devices and number of admissions, insufficient guidance for FDA, and poorly drafted submissions by the industry. In 2011, Dr. Shuren testified that concrete steps for improving the transparency, predictability and consistency of the premarket programs were outlined and evaluated. The Committee members generally focused on the sufficiency of CDRH/FDA's resources and an increase in review times for both the 510(k) and the Premarket Approval processes. One suggestion from Sen. Harkin (D-Iowa) was that the user fees for these submissions should be increased, although later it was conceded that the optimal solution would be if the FDA was independently funded.

The second discussion panel with Mr. Hall and Drs. Challoner and Curfman focused on the 510(k) process and the National Academies of Science, Institute of Medicine (IoM) report that heavily criticized the 510(k) process. Mr. Hall started first, outlining that the drug and medical device sectors are very different, including because medical device development is an iterative process that builds upon previously created devices, and clinical testing is not necessarily an optimal or feasible method of measuring safety and effectiveness for medical devices compared with drugs. In response to Sen. Harkin's question about 510(k) devices bearing little resemblance to each of its predicate devices that may compromise patient safety, Mr. Hall noted the FDA has resources and regulatory powers at its disposal to satisfy itself for any issues relating to safety and effectiveness. Mr. Hall also stated in response to Sen. Blumenthal's (D-Conn.) question that post-market surveillance should be improved but that currently, FDA does have controls and regulatory systems in place for monitoring. Mr. Hall also emphasized that the 510(k) process does control for safety and effectiveness.

The discussion with Dr. Challoner primarily focused on IoN's report, as he chaired the committee that drafted it. The IoN report concluded that the 510(k) process generally does not evaluate safety and effectiveness, but only evaluates whether it is substantively equivalent to prior devices previously cleared. He stated that the IoN committee concluded that overhauling the 510(k) process was an optimal scenario, but per Sen. Mikulski's (D-Md.) question, Dr. Challoner stated that he did not expect the 510(k) process be eliminated overnight. He considered the IoN report to be a conversation starter. Dr. Challoner also testified that since the 510(k) process will not be immediately overhauled, it may be necessary to evaluate and strengthen the post-market processes and improve quality control. Dr. Curfman provided testimony similar to Dr. Challoner, namely that post-market surveillance controls would be helpful in monitoring the safety and effectiveness of devices. One potential way of doing so would be to institute a uniform device identification system so that a device can be tracked over its lifetime.

Sen. Harkin, the Committee Chair, concluded that this hearing was helpful in illustrating the need to take a more intense look at the approval process and post-surveillance controls, especially for certain higher-risk devices. While Sen. Harkin conceded that user fees may not be the optimal solution to compensate for the FDA's lack of resources, he did not consider that any changes to this would be feasible in light of the current climate. Based on some of the discussion points raised during this hearing, the 510(k) process and the post-market surveillance requirements may see increased scrutiny.

A link to the videotaped hearing is here.