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:

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
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©Attorney Gordon S. Johnson, Jr. 2008

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:

“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
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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.

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:

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.

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.

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.

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©Attorney Gordon S. Johnson, Jr. 2008

Counterfeiting not an Unforeseeable Problem in Imported Heparin

The issue of counterfeiting imported drugs is neither new or unique to the Heparin disaster. In fact, this may be one of the biggest problems facing the pharmaceutical industry, worldwide. The FDA has devoted considerable resources to this issue for some time, including an entire portion of the FDA website, http://fda.gov to the issue of counterfeiting. See http://www.fda.gov/importeddrugs/

For example, at http://www.fda.gov/importeddrugs/chart071304.html the FDA reports its findings on three of the leading selling drugs that are being brought in from Canada: Ambien, Lipitor and Viagra. On all three of these drugs, the concentration level or purity (the same issues as with Heparin) are problems. For example, the above page says this about the safety of Viagra, a drug taken orally:

The sample tablets may be less clinically effective because of their reduced potency and poorer dissolution profile.

The sample tablets may also be less safe due to the elevated impurities.

This comment was made about a drug with only .7% impurities, unlike the up to 20% impurities in the contaminated heparin.

Clearly, both Baxter and SPL should have been on notice of the risk factors of contaminants and counterfeit in the raw material imported from China. With a drug intended for the human blood stream, that notice should have required the absolute utmost care.

Attorney Gordon Johnson
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FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc.

From the FDA:

Company manufactures and distributes unapproved and adulterated drugs
The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products.

Scientific Laboratories is a contract manufacturer and distributor of various prescription cough and cold products. The government's complaint, filed by the U.S. Department of Justice, alleged violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The company failed to seek required FDA approval for some of its products and failed to comply with current good manufacturing practice requirements (CGMP).

"The FDA will not allow a company to put the public's health at risk," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks."

The unapproved new drugs manufactured and marketed by Scientific Laboratories as prescription cough and cold products include: B-Vex Suspension, Ben-Tann Suspension, D-Tann Suspension, D-Tann AT Suspension, D-Tann CT Suspension, D-Tann DM Suspension, D-Tann HC Suspension, Dur-Tann DM Suspension, Duratan DM Suspension, L-All 12 Suspension, Nazarin Liquid, and Nazarin HC Liquid. Because these drugs have not undergone FDA review nor received approval, their safety and effectiveness have not been established. Additionally, the FDA has not reviewed the adequacy and accuracy of the directions and warnings in their labeling.

The FDA had warned Scientific Laboratories against violating the FD&C Act and about the risk of enforcement action if it failed to take corrective measures.

"The FDA will take action against companies and their executives who violate the law and endanger public health," said Margaret O'K. Glavin, associate commissioner for Regulatory Affairs. "The FDA will carefully monitor the provisions of this injunction as well as investigate and take action against other marketers of unapproved drugs."

The consent decree bars the defendants from manufacturing and distributing any drug until they obtain required FDA approval and fully comply with CGMP requirements. The defendants must destroy their illegal drugs. The consent decree also allows the FDA to order the defendants to shut down in the event of future violations. It also subjects the defendants to liquidated damages in the amount of $5,000 per day if they fail to comply with any of the provisions of the decree, and an additional sum of $5,000 for each violation, up to $1 million per year.

If patients have these products in their homes, they should discuss with their health care provider whether to discontinue use of the products and to find alternative therapy. Pharmacies should discontinue dispensing these products.

In June 2006, the FDA issued a guidance document titled, "Marketed Unapproved Drugs—Compliance Policy Guide" (CPG). This CPG makes clear that companies may not market drugs that require approval without first establishing, through applications for approval, that the products are safe and effective. The CPG also explains that FDA may take action against manufacturers and marketers of unapproved drugs that violate other provisions of the FD&C Act, including CGMP requirements.

The decree was signed Thurs., May 8, 2008 by Judge William D. Quarles, Jr., in the U.S. District Court for the District of Maryland

.

Attorney Gordon Johnson

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Baxter CEO Admits Responsibility for Heparin Disaster, Irrespective of Wrongdoing in China

Robert Parkinson, CEO of Baxter International, Inc. admitted in Congressional testimony on April 29, 2008 that because of the vulnerable patient population that receives Baxter's products, that Baxter and he are responsible for this disaster, regardless of how and when the contaminant OSCS got into the Heparin. Parkinson, testifying in front of House Oversight and Investigations Subcommittee, under oath, at 3:46 into the Hearing stated the following:

"Baxter has built its reputation over 75 years by consistently preparing quality products for critically ill patients.

"We deeply regret this has happened and I feel a strong sense of personal responsibility.

"I feel this because of who we are and what we do.

"Each day there are over 6 million infusions of Baxter products around the world to patients with life threatening conditions..

"We are not a traditional, pharmaceutical company. We don’t make pills or tablets. We don’t do direct to consumer advertising. And we don’t make lifestyle drugs.

"We develop and manufacture products that are injected, infused or inhaled, by patients who need them to stay alive. They have to be safe and effective each and every time.

"Because our products are used in critical care environments, they have to be safe and effective every time, no matter what the reason.

"This is my responsibility because Baxter’s name was on the product."

These statements form the fundamental basis of the lawsuit claims against Baxter International. Since the target patient population for all of Baxter's products are so medically vulnerable, Baxter had to take all precautions to assure safety.   According to the FDA, the precautions being taken in China were insufficient to identify contaminants or impurities.

With all that is known in the pharmaceutical industry about counterfeiting, Baxter should have been doing   more sophisticated testing for counterfeit or contaminant ingredients. Frankly, considering the now publicly apparent problems in regulating anything made in China, nothing that Baxter produces should be made from Chinese raw materials.

Attorney Gordon Johnson

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Hubley's Tell of Family Heparin Tragedy

Yesterday's blog was about the emotional investment it takes for my staff to listen to the tragic stories that people have as a result of the Heparin contamination. Today, I thought it might be important to focus in on one such story, not on one of our clients, but on the tragedy of Randy Hubley , as told to the House of Representatives in testimony last week.

Colleen Hubley, a dialysis nurse for 7 years, testified about her emotional experience from the contamination of heparin that caused the death of her husband. Her husband was a dialysis patient whose kidney transplant rejected in May 2006. Her prepared statement said that they were the first couple in Toledo area to do "home hemodialysis" (which is the provision of hemodialysis in the home of people with stage 5 chronic kidney disease). For the full prepared statement of Colleen Hubley, click here.

Two years later he had a surgery that he needed to start "in-center dialysis" and he started that at the Toledo Fresenius Clinic in Ohio. Later he was sent home to continue his hemodialysis routine. That is when Colleen says he began to get worse:

"This was the last week of his life. I wish I could tell you that at least the last few days of his life were good for Randy. I could take solace in that. However, the weekend prior to his death was awful."

Colleen tells about January 11, 2008, the day her husband's condition worsened:

"Randy [began to have] low blood pressure, severe diarrhea, abdominal pain, jaw pain, his throat was sore and felt "tight" to him, making him feel he needed his inhaler to breathe easier, something he didn't normally need too often. Because of this, he barely could make it to the restroom."

That night, she decided to sleep next to him on the couch. She was awoke to find him clutching is abdomen, unable to breathe and grabbing his chest. Colleen called 911 before he collapsed. She gave him CPR while her son helped her. When the paramedics arrived, they were barely able to get a breathing tube in his throat due to the swelling. Randy was taken to the ER and Colleen says,"[she was] notified that even if they got him back, it was hopeless."

She watched her husband die right in front of her eyes and there was nothing that could be done. Later she found out that his death might have been due to heparin contamination.

"As a nurse, I thought I would be there to save my husband from any errors, but I guess I was naive. I never thought that the lifesaving medication we were relying on might be contaminated."

Colleen Hubley asked that Baxter and the FDA take more responsibility to make sure that every drug that is given is free from contamination. Her sole purpose for sharing this tragedy, "to make sure this doesn't ever happen to anyone else. Please do not let his death be in vain, We, as a family, need to know that some good can come of this tragedy".

A tragic story, a story that puts a face on the statistics that the FDA has been publishing for months. But the Hubley family tragedy didn’t start with Randy. His mother, Bonnie Hubley, also died of a Heparin reaction, a month earlier. For the Prepared Statement of Leroy Hubley, Randy’s father, click here. Yes, a mother and son, under the same suspicious circumstances.

Why is it one family might have been struck twice by the same contaminant? Because both deaths occurred before the CDC and the FDA alerted the world about the recall on January 17, 2008. If it were just this family that was shattered by this poisoned, it would be a murder investigation centering in Ohio. But the coincidence isn’t forensically relevant when potentially thousands of others nationwide have been poisoned as well.

Bonnie Hubley’s death is not the first nor the last case where the diagnosis wasn’t understood, until this catastrophe became known. Until the extent of the contamination is fully disclosed by Baxter and other makers of Heparin, the real human cost of Baxter’s penny shaving decision to import intravenous drugs from China will not be known.

Attorney Gordon Johnson
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