Date: 07/27/2008 05:03 AM
By RICARDO ALONSO-ZALDIVAR
Associated Press Writer
WASHINGTON (AP) _ When federal regulators catch a drug company peddling prescription medications for an unapproved use, it takes them an average of seven months to issue a warning, according to a draft report by congressional investigators.
It typically takes four more months for the company to fix the problem. During that time, a lot prescriptions can be written.
The report from the Government Accountability Office delves into a gray area of medical practice and federal oversight: the use of medications to treat conditions other than the ones the drugs were approved for, a practice known as “off-label” prescribing.
Although widely accepted, off-label prescribing can amount to an uncontrolled experiment. While some patients benefit, others get drugs that do not do them much good and end up wasting their money. Some people have been harmed by unexpected side effects.
What makes the practice so difficult to get a handle on is a web of seemingly contradictory laws and regulations.
Drug companies are forbidden to promote medications for uses that have not been validated by the Food and Drug Administration on evidence from clinical trials. Doctors, however, can use their own independent judgment in prescribing medicines. Also, under guidance proposed by the FDA this year, drug companies could distribute to doctors scientific articles that suggest new and unapproved uses for medications.
The situation has raised concerns for Sen. Charles Grassley, R-Iowa, who fears that federal programs such as Medicare and Medicaid are paying billions for medications used for questionable purposes.
The review that Grassley requested found the FDA is ill-equipped to catch even blatant marketing abuses by drug companies. The agency does not have any staff exclusively assigned to monitor whether companies are following the rule against marketing drugs for unapproved uses.
Copyright 2008 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
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Proposal’s For Improved Use of Technology in FDA Monitoring
In our previous blogs, we have been discussing the testimony of Benjamin England, a former expert for the FDA as to the reasonableness of relying on the FDA to catch all counterfeiting and drug tampering. See England’s testimony on April 22, 2008, in front of the House Energy and Commerce Committee Hearings.
Click here for those England’s testimony: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042208.England-testimony.pdf
After discussing the foreseeability that a heparin type contamination situation could slip thru the FDA’s system, he made nine proposals for improved use of technology. They were:
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
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Click here for those England’s testimony: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042208.England-testimony.pdf
After discussing the foreseeability that a heparin type contamination situation could slip thru the FDA’s system, he made nine proposals for improved use of technology. They were:
1. “IT improvements recommended in the ISP are a contingency for executing any serious risk-targeting strategies for foreign inspections and import interdiction of unsafe drugs. This investment, however, cannot be targeted solely at drugs and devices, for the same operational systems must manage the other 90% of imported shipments and the inspection of other products. The IT fix must either be across all Centers and ORA or it must occur at the Department level to leave open the option of breaking food regulation out of FDA and combining it with other food regulators into a Food Safety Administration as a sister to the remaining Drug & Device Agency.”
2. “I continue to believe fixing FDA’s import and foreign inspection problem requires it be broken free from the domestic programs, which produce much of the bureaucratic inertia against change in this area. A new organization would enable proper staffing, allocation of human resources at ports of entry, management and implementation of ISP-based strategies. It should be responsible for all import and international focused work-planning activities; conducting facility inspections of foreign processors and importers; overseeing and conducting border operations; conducting foreign government and industry assessments and training; and support trade negotiations in a manner to enhance safety of imported products. To accomplish this, the new organization should be directly funded, rather than receiving its funding through the product Centers. A basic persistent infrastructure to manage risks associated with all imported commodities must be maintained regardless of year-to-year changes that may appropriately occur in program directions”.
3. “Section 302(b) of the Bioterrorism Act, which enables FDA to implement risk-based strategies for managing food imports, should be expanded to cover all other FDA- regulated products including drugs. This would clarify FDA’s authority to facilitate the importation of drugs that are in compliance with FDA requirements and pave the way for distinguishing between and among shipments based upon verifiable risk data”.
4. “ FDA should be required to inspect foreign drug facilities (at least those that fallinto categories FDA admits should be inspected on a regular basis) at the same frequency as domestic facilities.”
5. “FDA should work with Customs to adopt a uniform numerical identification system to begin the process of regulating its industries using an account-based system. This would enable FDA to integrate its numerous and disparate background data systems and to interrelate the data it receives from Customs and other government agencies”
6. “ FDA should publish and begin implementing the ISP in accordance with the plan’s guiding principles, goals, and themes.”
7. “FDA should begin developing programs for obtaining as much information as can be obtained from as many reliable sources as the agency can find regarding the cGMP compliance status and supply chain security programs of foreign drug facilities that are not inspected by FDA. This population of drug manufacturers will always exist, and simply saying it represents too many companies for oversight or too much data to digest is no answer at all.
Additional risk data could come in the form of third party inspection and certification companies, accompanied by a robust auditing process on both sides of the border, by foreign inspectorates, or by other U.S. Government Agency inspections and information. All such data should be connected to the firm’s unique identifier and incorporated into the account data to permit its assessment in light of other legacy and other agency data. I continue to hold to the view that obtaining and assessing all available risk data better enables FDA to (a) target its foreign and domestic inspections; (b) interdict and examine high-risk imported drug shipments (related to product safety); (c) follow up in the domestic market those shipments that proceeded through the border with inadequate inspections; and (d) facilitate imported drug shipments that are likely to have been manufactured in accordance with FDA’s cGMP requirements. This would permit the agency to focus its most earnest import inspection and examination efforts on shipments representing known and unknown risks.”
8. “FDA requires additional resources to conduct more foreign inspections and import examinations and to develop and publish meaningful Agency guidance relating to identifying and managing risks in the full life cycle of imported products.”
9. “FDA should rely on Customs and Border Protection and the Department of Homeland Security (DHS) to manage security risks associated with FDA regulated imports. DHS’ security programs should be expanded to incorporate product security risks (such as product counterfeiting and tampering) rather than focusing solely upon the security of in-transit cargo or inbound containers. “
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
FDA Lagging Technology Foreseeably Endangers U.S. Consumers
In our previous blog, we began our discussion of the testimony of Benjamin England, a long time FDA insider as to the foreseeability that the FDA as constituted, was not going to catch all counterfeiting and drug tampering. England’s testimony was part of Congressional hearings on April 22, 2008,
http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042208.DrugInspection.shtml
Click here for those England’s testimony: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042208.England-testimony.pdf
In his testimony, England discusses how the FDA has been behind for over a decade with technology and are not able to live up to their excepted duties:
England says that there is a struggle to simply register all the facilities and that all facilities may not even be in the data base, which creates an enormous problem for investigating.
Another problem is:
England goes on to say that this heparin problem could have been avoided if the FDA was able to obtain good solid evidence that the foreign facilities were operating within U.S. supervisions and guidelines. One of the ways England believes this can happen is “the physical FDA inspection of the facility making the bulk active pharmaceuticals and the finished dosage drugs.”
He also adds that the FDA inability to count to foreign facilities, also is a problem within a problem, because it could not count an accurate number on the foreign facilities that it has, the FDA can not accurately evaluate how effective their monitoring and safety measures are going.
England finally added nine proposals that he thinks the FDA can do to avoid similar problems in the future, which we discuss in our next blog.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042208.DrugInspection.shtml
Click here for those England’s testimony: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042208.England-testimony.pdf
In his testimony, England discusses how the FDA has been behind for over a decade with technology and are not able to live up to their excepted duties:
“As the General Accountability Office (GAO) has articulated several times over the last 15 years, the agency’s legacy data systems are antiquated and not integrated. The FDA has been striving for decades under a budget that is anemic with regard to IT funding.
England says that there is a struggle to simply register all the facilities and that all facilities may not even be in the data base, which creates an enormous problem for investigating.
“[FDA personnel] Humans are still entering data bases and checking to see if a registration, supplied during the importation process is “in” the system and
whether the number “belongs to” the manufacturer declared in an entry”.
Another problem is:
“FDA still receives its manufacturer declarations via the Customs Manufacturer Identification (MID) process and that MID must be translated in FDA’s systems to its own numbering system. Because of the variations in the MID process, FDA ends up with duplicate or triplicate numbers for the same facility — or far worse.”
“Portal overlays can help reduce the number of data base user names and
passwords an FDA official may have to remember – but they will not integrate data. These realizations, among others, account for at least some of the discrepancies in the agency’s data with respect to how many foreign facilities have been or should be inspected. This is an annoying result. But it is more than annoying when the lack of integration of data accounts for a regulatory regime which relies on a human to notice slight differences in company names to assess whether a facility has ever been inspected. In this regard, a unified registration system could quite easily have prevented the recent heparin scenario”.
England goes on to say that this heparin problem could have been avoided if the FDA was able to obtain good solid evidence that the foreign facilities were operating within U.S. supervisions and guidelines. One of the ways England believes this can happen is “the physical FDA inspection of the facility making the bulk active pharmaceuticals and the finished dosage drugs.”
He also adds that the FDA inability to count to foreign facilities, also is a problem within a problem, because it could not count an accurate number on the foreign facilities that it has, the FDA can not accurately evaluate how effective their monitoring and safety measures are going.
England finally added nine proposals that he thinks the FDA can do to avoid similar problems in the future, which we discuss in our next blog.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
Heparin Disaster -FDA Inspections Weren’t Sufficient to Rely on Safety of Drug
One of the lingering excuses for the Heparin Disaster is that it was the FDA’s responsibility, not the manufacturers, to make sure that Heparin was safe. That is like Wesley Snipes blaming overworked auditors for his tax fraud.
The risk factors of counterfeit drugs are known not only by drug companies like Baxter and SPL, but by the public at large. Every time we struggle to open a sealed package of anything we are reminded of why these seals are on these products: to avoid tampering. The risk of tampering and counterfeit are not something that can be transferred to an imperfect government auditing system, especially in light of what insiders have been saying for years about the thoroughness of FDA inspections.
In previous blogs, we have discussed the testimony before Congress: “Weaknesses Place Americans at Risk” Subcommittee on Oversight and Investigations held April 22, 2008. Click here for those hearings:http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042208.DrugInspection.shtml
During such hearings, Benjamin England, a former FDA inspector testified as to how inadequate the current FDA was to keep up with the problem of inspections.
In his testimony, England stated:
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
The risk factors of counterfeit drugs are known not only by drug companies like Baxter and SPL, but by the public at large. Every time we struggle to open a sealed package of anything we are reminded of why these seals are on these products: to avoid tampering. The risk of tampering and counterfeit are not something that can be transferred to an imperfect government auditing system, especially in light of what insiders have been saying for years about the thoroughness of FDA inspections.
In previous blogs, we have discussed the testimony before Congress: “Weaknesses Place Americans at Risk” Subcommittee on Oversight and Investigations held April 22, 2008. Click here for those hearings:http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042208.DrugInspection.shtml
During such hearings, Benjamin England, a former FDA inspector testified as to how inadequate the current FDA was to keep up with the problem of inspections.
Click here for those England’s testimony: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042208.England-testimony.pdf
In his testimony England described his background as follows:
In his testimony England described his background as follows:
I am founder and owner of an FDA consulting practice, FDA Imports.com, Inc., and a practicing attorney representing foreign and domestic food, drug, medical device and cosmetic companies in matters involving the U.S. Food and Drug Administration (FDA). I am a 17-year veteran of the U.S. Food and Drug Administration (FDA). From 1986 to 2003 I held the positions of Regulatory Microbiologist in FDA’s Baltimore Microbiology Laboratory, Consumer Safety Officer and Compliance Officer in FDA’s Baltimore District Office, Special Agent with FDA’s Office of Criminal Investigations in the Miami Field Office, Compliance Officer in FDA’s Miami Resident Post, and Regulatory Counsel to FDA’s Associate Commissioner for Regulatory Affairs (or ACRA) in Headquarters. I resigned my most recent FDA position as Regulatory Counsel to the ACRA in July 2003 — a position I held in FDA for over three years as a Title 42 appointee.
In his testimony, England stated:
Today we are confronted with serious adverse events involving a widely used drug product that appears to have been made using substituted active ingredients at a foreign facility that was never inspected by FDA – because of some human error in deciding whether an inspection had already been conducted or should be conducted. I believe that we are truly on the brink of a series of these events and that waiting for FDA to take some action that actually mitigates risk or encouraging the agency to act unilaterally will be an exercise in futility. As I said in the press and to your staff, Mr. Chairman, this recent case appears to be the close cousin of the same conduct discovered nearly two decades ago. At that time, it was through intensive and smart facility inspections and by the efforts of forward thinking forensic scientists and investigators the activity was discovered. Moreover, the successfully prosecuted counterfeit bulk drug case was made possible only through the intellectual connections between certain domestic inspections at U.S. facilities by a keen FDA investigator who had previously conducted the foreign inspection of the bulk supplier, coupled with follow up inspections at the foreign supplier, which were themselves targeted with knowledge of where evidence of illegal conduct was likely to be found.In our next blog, we will discuss England’s perspective on the FDA’s failures to use those technological advances to prevent tampering and contaminants in imported drugs.
It is no different today – except that we now have available to us significantly improved technological solutions that may prove useful to more precisely and efficiently identify, target, and intercept safety risks prior to their realization in the market place.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney