Life Science Compliance Update

5 posts categorized "GAO"

December 30, 2013

HHS Duplicative Databases Slows Enforcement Efforts

The Government Accountability Office (GAO) published a report highlighting the important role oversight and law enforcement agencies play in eliminating fraud, waste, and abuse.

The report found "more than $300 million in duplicative IT systems at three different government agencies, including the U.S. Department of Health & Human Services--which has six duplicative systems costing $256 million alone," reported FierceHealthIT. The six potentially duplicative investments at HHS include four investments that support enterprise information security and two for Medicare coverage determination, according to GAO.

"With so much money on the line, it is critical that our government agencies are doing everything possible to save taxpayer money," Sen. Tom Carper (D-Del.), chairman of the Senate's Homeland Security Committee, said in a statement. "An important part of this effort is to ensure that we are not investing in programs that unnecessarily overlap or are duplicative."

In January 2013, GAO, the Council of the Inspectors General on Integrity and Efficiency, and the Recovery Accountability and Transparency Board convened a forum with the purpose of exploring ways in which oversight and law enforcement agencies use data analytics to assist in the prevention and detection of fraud, waste, and abuse, as well as identifying the most-significant challenges to realizing the potential of data analytics and actions that the government can take to address these challenges. HHS OIG played a significant role in helping plan and conduct this forum.

The report summarizes the key themes that emerged from the discussion in the forum. Specifically, the report discusses the challenges and opportunities in (1) accessing and using data and (2) sharing data. In addition, participants identified next steps to address these challenges and capitalize on opportunities.

Though participants pointed to the Center for Medicare & Medicaid Services' (CMS) Fraud Prevention System as an example of harnessing data through predictive modeling and other analytics, the report says of government efforts overall, that "despite these efforts, the path to capitalizing on the potential of data analytics is not a clear one."

Participants said they're not always aware of all the data sources available for addressing fraud, that they'd like to see a database of known offenders and also pointed out that government program offices lack incentives to develop IT systems useful in oversight efforts, reported FierceHealthIT. They cited other challenges including:

  • An overwhelming amount of available data and difficulties setting priorities
  • The various legal implications of owning and maintaining data, including an array of regulations such as Freedom of Information Act disclosure requirements, HIPAA and others
  • Difficulty measuring the success of analytics programs

Participants also said that federal and state government agencies are not working from a single set of data standards, which makes integrating systems and interpreting the various data elements difficult. Among the lessons learned, participants said that:

  • Having analytics tools isn't enough; it's crucial to have well-trained staff to perform data analysis, identify high-quality investigative leads and areas of greatest risk
  • Building support for analytics from top management down also is essential
  • Data and analytics operations must be consolidated into one location to enhance effectiveness and return on investment
  • Parties responsible for retaining and maintaining databases must be identified to ensure proper safeguards are in place to protect privacy

The forum proposed actions including:

  • Addressing statutory challenges related to data access and use
  • Developing an ongoing community of practice focused on data-sharing challenges
  • Compiling a library of available open-source data analytics, modules, and tools

HHS officials disagreed that its information security investments were duplicative, but nonetheless plan to review them this month to "identify opportunities for consolidation." As for the Medicare coverage determination investments? HHS officials noted that they have "consolidated several functions but could not provide documented justification for why the other functions were not consolidated."


June 13, 2012

GAO Reports Vulnerabilities in CMS Payment Oversight

Data Problems
In 2011, CMS estimated that Medicaid and Medicare had improper payments of $21.9 billion and almost $43 billion, respectively—among the largest for all federal programs. Both health care programs are on GAO’s list of high-risk programs.  Over the years, Congress has passed legislation designed to help address program integrity issues in the two programs but they remain vulnerable to fraud, waste, and abuse. 

The Patient Protection and Affordable Care Act (PPACA) also included several provisions aimed at strengthening Medicaid provider enrollment standards and procedures.  For example, PPACA required states to conduct certain provider screening procedures, such as verifying provider licenses and terminating individuals or entities from Medicaid participation under certain circumstances. 

A recent report from the Office Government Accounting Office (GAO) recognized that although the Centers for Medicare and Medicaid Services have taken certain actions to help fight fraud, waste and abuse, “other actions remain undone.” 

In addition to the report, testimony was recently given by Ann Maxewell, Regional Inspector General for the Office of Evaluations and Inspections of OIG, before the House Committee on Oversight and Government Reform: Subcommittee on Government Organization, Efficiency and Financial Management.   Other testimony was presented by Robert A. Vito, also a Regional Inspector General. 

Maxwell’s testimony was based on several evaluations recently issued by OIG that focused on two national Medicaid integrity programs intended to augment States’ efforts to protect Medicaid from fraud, waste, and abuse.  OIG’s work revealed that these programs are not effectively accomplishing their missions. 

A primary objective for both programs is to identify improper payments for recovery. However, both programs had low findings of actual overpayments and, as a result, yielded negative returns on investment.  These programs also delivered very few referrals of potential fraud to OIG and our law enforcement partners. In many ways, these programs resemble a funnel through which significant Federal and State resources are being poured in and limited results are trickling out. 

GAO Report 

GAO focused on four key strategies and recommendations that were designed to facilitate them that were identified in prior work and that could help reduce improper payments: (1) strengthening provider enrollment standards and procedures to ensure that only legitimate providers participate in the program; (2) improving prepayment controls; (3) improving postpayment claims review and recovery of improper payments; and (4) developing a robust process for addressing identified vulnerabilities. This statement is based on CMS products issued from April 2004 through May 2012 and interviews with agency officials and other stakeholders. 

For the Medicaid program, CMS and the states have taken actions related to GAO’s four key strategies but more needs to be done. 

  • CMS’s comprehensive state program integrity reviews identified provider enrollment as the most frequently cited area of concern but the agency has noted a positive trend in states’ awareness of regulatory requirements.
  • CMS noted vulnerabilities in the prepayment reviews of claims in five states and effective practices in seven others. In anticipation of new analytic tools to predict vulnerabilities before claims are paid, the agency has initiated discussions with and provided guidance to states.
  • CMS has begun collaborating with states to identify targets for federal postpayment audits, which should help to avoid duplication of federal and state audit efforts.
  • CMS has not established a robust process for states to evaluate and address vulnerabilities identified by the states’ new recovery audit contractors brought in to identify improper payments and recoup overpayments.  

For the Medicare program, CMS has acted to strengthen several of its strategies to better ensure program integrity, but other actions remain undone. 

  • Congress authorized CMS to implement several new or improved enrollment safeguards, including screening enrollment applications for categories of Medicare providers by risk level. CMS has issued a final rule to implement this and other changes, but has not completed other final rules and additional actions that could further strengthen enrollment procedures, such as rules to implement new surety bond provisions and provider and supplier disclosures.
  • GAO’s prior work found certain gaps in Medicare’s prepayment edits based on coverage and payment policies and made recommendations for improvement, such as adding edits to identify abnormally rapid increases in medical equipment billing. GAO is currently evaluating new CMS efforts in this area.
  • CMS has begun using recovery auditing in its prescription drug program but not for its Medicare managed care plans.
  • GAO recommended that CMS establish an adequate process to ensure prompt resolution of identified vulnerabilities in Medicare and is currently evaluating steps that CMS has taken recently.

March 14, 2012

GAO Report Drug Pricing: Research on Savings from Generic Drug Use

Generic Drugs
Since the Drug Price Competition and Patent Term Restoration Act of 1984—commonly known as the Hatch-Waxman Act—generic drugs have been touted as one of the greatest way to generate savings in federal health care programs.  In fact, over 75% of prescription drugs prescribed in America today are generics.  

The use of generics is significant because prescription drug spending in the United States reached $307 billion in 2010—an increase of $135 billion since 2001—and comprised approximately 12 percent of all health care spending in the country. Until the early 2000s, drug spending was one of the fastest growing components of health care spending.  However, since that time, the rate of increase has generally declined each year, attributable in part to the greater use of generic drugs, which are copies of approved brand-name drugs. 

Generic versions of brand-name drugs become available to consumers when brand-name drugs’ patents and periods of market exclusivity expire and generic manufacturers obtain approval to market their drug.  The competition that brand-name drugs face from generic equivalents is associated with lower overall drug prices, particularly as the number of generic manufacturers grows and price competition among them increases.  On average, the retail price of a generic drug is 75 percent lower than the retail price of a brand-name drug. 

Despite the potential savings generics have created, a recent report from the Government Accountability Office (GAO) found that, “Studies looking at cost savings from use of generic drugs "had mixed results regarding the effect of using these generics, in that some found they raised healthcare costs, while others found they led to cost savings."  Specifically, the report found that in some instances, the use of generics led to increased costs due to hospitalizations, emergency department visits, physician visits, and higher dosages of products. 

The report was conducted at the request of Senator Orrin Hatch (R-UT), author of the Hatch-Waxman Act.  Senator Hatch asked GAO to identify research completed on estimates of cost savings from the use of generic drugs in the United States.  The report summarizes the findings of peer-reviewed articles, government reports, and studies by national organizations, including trade and nonprofit organizations, on this topic. 


The Hatch-Waxman Act facilitated earlier, and less costly, market entry of generic drugs, while protecting the patent rights of brand-name drug manufacturers, to encourage continued investment in research and development.  When the act was enacted in 1984, the generic utilization rate—which is the share of all drugs dispensed that are generic—was about 19 percent.  Today it is about 78 percent for drugs dispensed in retail settings, such as independent, chain, and mail-order pharmacies, as well as in long-term care facilities. The generic utilization rate is expected to continue to grow over the next few years as a number of blockbuster drugs come off patent through 2015. 

While the Hatch-Waxman Act has helped to increase the number of generic alternatives to brand-name drugs, other factors influence whether providers and consumers use generic drugs.  For example, third-party payers—including private health insurance plans and public programs such as Medicare— use strategies such as tiered copayments to encourage the use of less expensive drugs within a therapeutic class, which are often generics.  Also, perceptions of the safety and efficacy of generic drugs may affect their use.  Thus, use of generic drugs—and the savings realized—can vary by payer as well as across therapeutic classes. 

In order to be approved by the U.S. Food and Drug Administration (FDA), generic drugs must be the same as their brand-name counterparts in the following ways: 

  • They must have the same active ingredient(s);
  • The same route of administration, for example, a drug that is taken orally versus by injection;
  • The same dosage form, for example, a pill versus a syrup;
  • The same strength; and
  • The same intended use.  

Generic drugs also must meet FDA manufacturing standards and be bioequivalent, meaning that the rate and extent of absorption of generic drugs into the bloodstream do not show a statistically significant difference from their brand-name counterparts. However, bioequivalence standards set by FDA allow for variation between brand and generic drugs that is considered small enough for the drugs to still be considered interchangeable.  Such variation may occur because, for example, generic drugs may have different inactive ingredients, such as binding materials, dyes, preservatives, or flavoring agents compared to brand-name drugs. 

Once generic drugs are approved by FDA, providers and consumers may substitute them for their bioequivalent, brand-name counterparts.  They also may substitute generic drugs for brand-name drugs that are not bioequivalent, but are within the same therapeutic class.  While generic substitution is generally considered medically appropriate, there are a number of circumstances under which therapeutic substitution may not be appropriate. For example, some drugs in a therapeutic class either may be more effective than others for certain individuals or may not be safe for people with complicating health conditions. Ggeneric and therapeutic substitution make up the generic utilization rate (that is, the share of all drugs dispensed that are generic), which may be affected by a number of factors.  One important factor is “perceptions of generic drugs’ safety and efficacy.” 

Physicians, pharmacists, and consumers may have perceptions about the safety and efficacy of generic drugs compared to brand-name drugs, which in turn affect what drugs they choose to use. These perceptions are based on a number of factors, including prior experience, results of relevant studies, or advertising.  Negative perceptions of generic drugs may be more common where questions have been raised about the medical appropriateness of generic or therapeutic substitution.

For example, there is controversy within the health care community about whether generic substitution is appropriate for drugs for which there are relatively small differences between the therapeutic dose and doses that could lead to serious treatment failure or serious adverse drug reactions. These drugs are referred to as having a narrow therapeutic index (NTI) and are commonly understood to include anti-epileptic drugs, thyroid drugs, and immunosuppressant drugs. 

GAO Report 

GAO’s report found three types of studies.  One group of studies estimated the savings in reduced drug costs that have accrued from the use of generics.  For example, a series of studies estimated the total savings that have accrued to the U.S. health care system from substituting generic drugs for their brand-name counterparts, and found that from 1999 through 2010 doing so saved more than $1 trillion. 

A second group of studies estimated the potential to save more on drugs through greater use of generics.  For example, one study assessed the potential for additional savings within the Medicare Part D program—which provides outpatient prescription drug coverage for Medicare—and found that if generic drugs had always been substituted for the brand-name drugs studied, about $900 million would have been saved in 2007. 

The third group of studies estimated the effect on health care costs of using generic versions of certain types of drugs where questions had generally been raised about whether substituting generic drugs for brand-name drugs was medically appropriate. Unlike the other two groups which focused on savings on drugs only, these studies compared savings from the lower cost of generic drugs to other health care costs that could accrue from their use, such as increased hospitalizations.  

Effect of Using Generic Versions of Certain Types of Drugs on Health Care Costs 

The studies in group three estimated the effect on health care costs of using generic versions of certain types of drugs where questions had generally been raised about whether substituting generic drugs for brand-name drugs was medically appropriate; the research found mixed results about whether generic drugs lowered health care costs in these circumstances. 

These studies compared savings from the lower cost of generics to other health care costs that might accrue from their use, such as increased hospitalizations, emergency department visits, or physician visits. These studies were generally limited to particular types of drugs where the medical appropriateness of generic or therapeutic substitution has been debated.  Studies that looked at generic substitution focused on NTI drugs, whereas studies that looked at therapeutic substitution did not focus on NTI drugs.   

For example, studies that looked at therapeutic substitution examined selective serotonin reuptake inhibitors (SSRIs), which are currently among the most widely prescribed antidepressants in the United States.  Most studies used a regression analysis for the estimate to account for the potential impact of confounding variables, such as comorbidities on health care costs.   

One study examined claims data from 1996-2004 for renal transplant patients in eight private health insurance plans to examine the effect of generic substitution of an NTI immunosuppressant drug on health care costs.  The study found that total healthcare costs 12 months after transplantation were higher for those initiating therapy with the generic immunosuppressant drug at $36,482 versus the brand version at $32,171. This study did not find a difference in hospitalization or physician costs. Rather, the study found that the main reason for the difference was the cost associated with needing higher doses of the generic drug or additional immunosuppressants needed to maintain the transplanted kidney in patients using the generic. 

A second study used claims data from 1998 for approximately 2,300 privately insured patients to determine the effect of generic substitution of an NTI anticoagulant drug when a switch occurred midtreatment.  The study compared treatment costs associated with using the brand and generic version of the drug and found that, based on data from 90 days before and the 90 days after the switch, the difference in total costs associated with the brand and generic anticoagulant drug was $3,128 less per 100 patient years for the generic. 

Another study used claims data from about 45 private health insurance plans from 2003 to 2007 to compare health care costs over 6 months in patients using brand and generic SSRIs when therapeutic substitution occurred midtreatment.  The study found that, on average, compared with patients who remained on brand-name drugs, patients who switched to generic drugs experienced an increase of $881 in total health care costs.  Among other factors leading to the increased costs, patients who switched from brand-name drugs to generic drugs had higher rates of hospitalizations and emergency department visits than did patients who remained on the brand-name drug. 

A fourth study reached a different conclusion about the effect of using generic SSRIs, when patients began treatment with a generic drug.  This study used claims data from 2005 to 2007 and compared health care costs for a 6-month period in patients in about 100 private health insurance plans. The study concluded that the total health care costs of patients using generic antidepressants were significantly lower than costs of patients using brand antidepressants, with an average of $3,660 and $4,587 respectively. 


While the report shows mixed results of the cost-effectiveness of generics, it is important that people understand the potential additional costs generics can have to patients for generic substitutions of an drug with a Narrow Therapeutic Index.  

March 09, 2010

GAO Recommends the FDA to Strengthen Investigation Oversight

Within the Food and Drug Administration (FDA) is the Office of Criminal Investigations (OCI), which investigates individuals and companies external to FDA. In addition, FDA also has the authority to investigate allegations of FDA employee misconduct through internal investigations conducted by the Office of Internal Affairs (OIA), a distinct office within OCI. Over the last decade (1999 to 2008), the Government Accountability Office (GAO) was asked to examine three particular areas within these offices:

-    oversight of OCI investigations;

-    oversight of OIA investigations; and   

-    funding, staffing, and workload for OCI.

In order to carry out this study, GAO interviewed agency officials, reviewed FDA documents including those describing its investigative policies, and examined FDA data on OCI resources and workload, from fiscal years 1999 to 2008. The final report, which was recently issued, is titled Improved Monitoring and Development of Performance Measures Needed to Strengthen Oversight of Criminal and Misconduct Investigations.” The report found that:

- FDA's funding for OCI generally increased annually between fiscal years 1999 and 2008 ($19 million in fiscal year 1999 to over $41 million in fiscal year 2008, a 73% increase);

- FDA’s staffing for OCI increased by about 40 percent during this period, from about 165 full-time equivalent employees to over 230;

- OCI's investigative workload also increased 27 percent over this 10-year period;

- the number of cases that OCI’s criminal investigators actively worked at the end of a fiscal year increased by 66 percent, from 655 to 1087; and

- Of the 24 total office assessments that should have been completed by August 2009, only 7, or about 30 percent, were completed and one office had not been assessed in over 10 years;

One of the issues that GAO found was that although OCI has policies to guide its investigations of individuals and companies external to FDA, FDA’s oversight of OCI’s criminal investigations is limited. In particular, FDA has not ensured OCI’s compliance with investigative policies and procedures within prescribed time frames. Additionally, the report found FDA lacks performance measures that could enhance its oversight of OCI by allowing it to assess OCI’s overall success. For example, there is no requirement for OCI to report regularly on specific topics to FDA senior-level offices as part of the formal reporting relationship, leaving the OCI Director to determine which aspects of OCI’s operations and investigations are made known to FDA’s top management.

According to the OCI Director, some of these issues occur because of limited resources and logistical issues, which have prevented FDA from assessing field office compliance with OCI’s investigative policies and procedures every 3 years. Another reason why OCI has little control over the outcome of cases is because investigations priorities often affect staffing and resources within a U.S. Attorney’s Office and may indirectly affect the ability of the office to proceed on every matter presented for prosecution.




In response to the report, Senator Charles Grassley (R-IA), noted that the “report has made a difference already by securing a much needed commitment from the Commissioner to make the FDA’s investigative unit live up to its significant responsibilities.”  He added further that there was “no excuse for the fact that this division’s failures have gone unchecked for years, and having the FDA leadership focused on fixing what’s broken is the first, very important step needed.”


One nuance to the report is that OCI’s investigative load increased over the time frame studied. Although staffing and funding were also increased, the GAO did not comment on the ability for additional funds and staff to address the increased case load. It is unlikely however, that staffing and funding was enough since the OCI Director cited “limited resources” as one of the reasons why investigations were not continued and conducted.


The commitment Senator Grassley was referring to came from a letter written by FDA Commissioner Hamburg, who asserted that the agency is currently developing meaningful performance measures for OCI, in response to GAOs recommendations. Dr. Hamburg also noted that the agency is “implementing other significant efforts that address the issues in GAO’s report to enhance coordination, communication and strategic alignment of public health priorities between OCI and other Agency components.” She also indicated that a new committee was formed in August 2009 with members from various health agencies (e.g. CMS, HHS, etc.) to address regulatory priorities and activities.


With regards to the issues found in GAO’s report, Dr. Hamburg asserted that OCI is conducting outreach to the Centers and District Offices to better educate them about OCI’s role and responsibilities. She also addressed the fact that FDA is now developing criteria to include in its revised policies for consideration in selection of misdemeanor prosecution cases to hold “responsible corporate officials accountable.”



GAO concluded its report with the following three recommendations:

· To ensure OCI's compliance with investigative policies the Secretary of Health and Human Services (HHS) should instruct the Commissioner of FDA to have regular assessments of OCI's field offices conducted in accordance with its existing policy.

· To ensure OIA's compliance with investigative policies, the Secretary of HHS should instruct the Commissioner of FDA to establish a review procedure for the assessment of OIA's compliance with its investigative policies.

· To assess whether OCI's criminal investigative program is achieving its desired results, the Secretary of HHS should instruct the Commissioner of FDA to establish performance measures and assess program results against them. 



While it seems clear that FDA has already begun implementing such changes and addressing the concerns of GAO, paying attention to the problems the OCI Director spoke of are equally important.  

Prosecuting company officials and increasing the use of disbarment or disqualification can have a chilling and negative effect on developing new and innovative technologies and treatments.

Prosecutions for headlines should be avoided when OCI specifically noted that a problem with these investigations is that as the number of cases increases, the number of resources are limited (staff and funding). As a result, before any extreme measures are implemented, FDA should consider what increasing more resources to OCI would do to ensure better compliance with GAOs recommendations and which of those recommendations will actually keep us safer.

November 03, 2009

GAO to FDA: Action Needed to Improve Timeliness on Clinical Investigator Oversight

The Government Accounting Office ("GAO") published a new report on the oversight of clinical investigators titled, “Oversight of Clinical Investigators: Action Needed to Improve Timeliness and Enhance Scope of FDA’s Debarment and Disqualification Processes for Medical Product Investigators.” The report offers a critical look at the process FDA uses in such oversight by citing numerous instances where FDA did not take timely action to respond to situations where debarment or disqualification of a clinical investigator was at issue. 

Under Federal Food, Drug, and Cosmetic Act ("FDC Act"), debarment is mandatory if an individual has been convicted of a felony under federal law for conduct relating to the regulation of a drug.  A mandatory debarment is permanent.  In a permissive debarment, FDA may debar an individual if he or she has been convicted of a misdemeanor under federal law or a felony under state law if the conduct relates to the development or approval process of a drug, or if the individual has been convicted of certain felonies not related to drug development.  Permissive debarment is for a period of time up to five years. 

Pursuant to FDA regulations, FDA may also disqualify investigators (i.e., determine that a clinical investigator is not entitled to receive investigational drugs or devices) who repeatedly or deliberately fail to comply with FDA regulations or report false information to FDA or a trial sponsor.

Since the seriousness of these charges are profound, GAO’s report reviewed factors contributing to delays in FDA’s debarment and disqualification proceedings such as (1) the length of time FDA’s debarment proceedings have taken and the factors contributing to the length of time they have taken, (2) the length of time FDA’s disqualification proceedings have taken and the factors contributing to the length of time they have taken, and (3) statutory and regulatory limitations to debarment and disqualification.

The GAO reviewed 18 debarment proceedings and 52 disqualification proceedings between May 13, 1992—when FDA was first given the authority to take such actions—through September 9, 2008. The results of the report found that debarment proceedings ranged in length from 26 days to more than a decade. For debarment proceedings, 13 involved clinical investigators and 5 involved study coordinators. More than half of the debarment proceedings took over 4 years, and the median length for a proceeding was 4.4 years.  The median length for a disqualification proceeding was 2.5 years, with over a third of the proceedings taking more than 2 years. 

GAO also reported that permissive debarment proceedings generally took longer than mandatory proceedings. Of the 11 completed debarment proceedings, 5 were permissive debarment proceedings that took 4 or more years from conviction to debarment, with a median of 5.0 years. In contrast, six completed mandatory debarment proceedings took from just over 1 year to just over 6 years from conviction to debarment, with a median of 3.1 years.

Also for debarment proceedings, those involving individuals generally took longer to complete. Five of the 18 proceedings we reviewed involved individuals who responded to FDA’s proposal to debar letter by requesting a formal hearing to contest debarment. These proceedings took from 6 months to about 6 years, with a median of 2.2 years, from FDA’s issuance of a proposal to debar letter

As a result of such delays, the report acknowledged that the FDA is working to improve its debarment and disqualification procedures and will “endeavor to incorporate” the GAO’s recommendations. FDA also stated that the Agency would be drafting a guidance document to explain the disqualification process. 

Accordingly, the FDA identified several factors that contributed to the length of time taken to complete the debarment proceedings. These factors included:


-   A lack of systematic procedures to help ensure timely communication of information relevant to debarment (such as conviction information);


-   A lack of policies, expectations and procedures for FDA staff that established time frames for debarment actions;


-   Limited resources due to competing priorities;


-   A lack of communication between staff responsible for debarment and other FDA staff having information on convictions


Although some of these factors are being dealt with presently by the FDA, the report addresses that the results are still unknown, and problematic. For example, implementing the new time frames that FDA has established for debarment and disqualification could be challenging because some of these time frames are substantially shorter than the times FDA actually took in the proceedings we reviewed. Additionally, given the agency’s competing priorities, it remains to be seen whether FDA will dedicate sufficient resources to debarment or disqualification proceedings to meet the time frames.

GAO summarized its report by offering recommendations to strengthen FDA’s oversight of clinical investigators (GAO Report page 43):

· Pursue debarment authority for medical devices that is consistent with the current debarment authority for drugs and biologics and prohibit any debarred individual from involvement with drugs, biologics, and medical devices.    

· Amend FDA regulations to ensure that those who have engaged in misconduct found sufficiently serious to warrant disqualification for one investigational medical product are not able to continue to serve as clinical investigators for any.    

· Monitor compliance with recently established time frames for debarment and disqualification proceedings and take appropriate action when those are not met.

The problems with FDA’s oversight into debarment and disqualification highlights the limited resources and time the agency has. By continuing such an inefficient process, the FDA is preventing companies and researchers from creating life saving devices and medicines that will save lives. While it is important to have oversight, these proceedings must be made timelier to help more patients, and to keep businesses funding such breakthroughs in order to advance science and educate physicians.


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