Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Susan Haigney

The deadline for the implementation of California’s prescription drug tracking system, ePedigree, has been delayed until January 2011. Stating that some industry manufacturers and distributors were having a difficult time coming up to speed on implementation requirements by the original January 2009 deadline, the California State Board of Pharmacy decided on March 25 to postpone the deadline for two years. 

The delayed implementation comes after drug manufacturers expressed concerns about standardization issues as well as the complex regulation involved, changes to packaging, and the cost of implementation. The State Board of Pharmacy acknowledged in its ruling that while some companies have been moving forward with the program at a good pace, others have lagged behind. “This board recognizes that this sort of comprehensive model is not easily implemented and that it has required and will require significant efforts by industry participants. After consideration of all the evidence presented to the Board…the Board concurs that the additional two years to January 1, 2011 is [required…] in order to implement electronic technologies to track the distribution of dangerous drugs within the state,” stated William Powers, president of the California State Board of Pharmacy. The board also stated that the delay would give it time to work with FDA to develop standards consistent with Federal guidelines.

The ePedigree system is a part of California’s ongoing effort to combat counterfeit drugs and ensure drug safety. California legislation requires an electronic system be developed to track and trace prescription drugs from manufacture to pharmacy. This tracking system would follow a drug’s path along the distribution line including updates to records if and when a drug moved from one pharmacy chain to another. Information obtained would include prescription name, manufacturer name, dose, container size, lot or control number, purchaser names and addresses, sale dates, and shipping information.

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The deadline for the implementation of California's prescription drug tracking system, ePedigree, has been delayed until January 2011.

California's ePedigree Delayed

Eli Lilly terminated the development of its inhaled insulin product AIR, a diabetes treatment that had been in Phase III clinical trials. In a March 7 press release, Lilly’s president and chief operating officer John Lechleiter stated that the decision was due to an uncertain regulatory environment, saying, “Without the prospect of a new drug application, keeping the patient foremost in mind, it would not be consistent with our medical principles to continue the clinical trials.”

Quelling concerns of patients involved in the clinical trials, Lilly stressed its decision was not based on product safety. Lechleiter reassured that “patients currently receiving AIR Insulin in our ongoing clinical trials should have no health or safety concerns about continuing to use AIR Insulin during their transition to other well-established diabetes therapies.” Lilly’s executive vice-president of science and technology, Steven M. Paul, reaffirmed that “our decision is not due to any safety concerns observed by Lilly or raised by the independent data safety monitoring board.” Lilly plans on implementing a patient assistance program to provide trial patients in the US with financial support to help fund medications and diagnostic supplies through the end of 2008. Paul says Lilly “remains committed to our mission to develop innovative, beneficial, and cost-effective treatments for diabetic patients.” 

AIR was a joint project between Lilly and Alkermes. In a statement released on March 7, Alkermes stated that Lilly was within its rights to terminate its license to AIR Insulin but that Alkermes believes Phase III safety and efficacy trials should be completed to provide patients, physicians, and scientists with more information on inhaled insulin and other diabetes medications.

While Lilly, Pfizer, and other companies have discontinued similar products, MannKind, which is developing its own version of inhaled insulin, issued a statement on March 10 that it was committed to developing its product and believes that its “small, patient-friendly ‘Medtone’ inhaler delivers ‘Technosphere Insulin’ to patients with diabetes in a way that much more closely matches the pattern of insulin secretion seen in people without disease.”

Eli Lilly terminated the development of its inhaled insulin product AIR, a diabetes treatment that had been in Phase III clinical trials.

Eli Lilly Terminates AIR Insulin Program

The US Food and Drug Administration recently revealed that the active ingredient used in the production of 

’s recalled drug Heparin was made in a plant in China. FDA and Baxter are both stating that it is not known at this date what role the ingredient may or may not have played in the approximately 350 adverse reactions and four deaths possibly caused by the blood thinner. 

The involvement of a Chinese factory in the production of a recalled drug raises the continued concern regarding Chinese-made products. According to the 

, China is the “world’s largest producer of active pharmaceutical ingredients.” The 

 states that FDA is not required by law to inspect foreign manufacturing facilities but makes it a general rule to do so. FDA admitted it had not inspected the particular Chinese plant due to a mistake in paper work, but plans for the inspection of the plant are under way. The agency has requested that the facility provide inspectional data and adverse event reports regarding the possibly tainted drug. Critics say that the failure of FDA to inspect foreign manufacturing facilities continues to put consumers and patients at risk. 

 that the company has had a 20-year relationship with the supplier and that the supplier has made the specific active ingredient for 30 years. According to the spokesperson, no changes were recently made at the Chinese plant and it is unsure if there is any connection between the plant and the adverse drug effects.

Baxter temporarily halted production of heparin last week due to reports of four patient deaths and allergic reactions that included stomach pain, vomiting, low blood pressure, fast heart rate, and fainting. Baxter is a major producer of heparin, providing half of the nation’s supply. 

(Schaumburg, Illinois) acquires the active ingredient for their heparin blood thinner from a Chinese plant as well but has, reportedly, not experienced the same kinds of adverse effects.

The US Food and Drug Administration recently revealed that the active ingredient used in the production of Baxter International Inc.'s recalled drug Heparin was made in a plant in China.

Active Ingredient in Baxter's Recalled Heparin Made in China

-The US Food and Drug Administration has issued a not approvable letter to Merck & Co. in regards to their request for over-the-counter (OTC) use of “Mevacor” (lovastatin) 20 mg. FDA’s letter indicates a revised label would be required as well as additional data from Merck. 

This decision follows the FDA’s Nonprescription Drugs Advisory and Endocrinologic and Metabolic Drugs Advisory committees’ recommended 

.  Edwin L. Hemwall, PhD, Merck’s Vice President of Global OTC Regulatory and Scientific Affairs, said the company is “evaluating the conditions outlined in the agency’s response to determine a path forward for ‘Mevacor’ OCT.”

Under review by FDA since 1999, not approvable letters were also issued in 2000 and 2005. “Mevacor” is designed to reduce LDL cholesterol levels in patients.

The US Food and Drug Administration has issued a not approvable letter to Merck & Co. in regards to their request for over-the-counter use of "Mevacor" (lovastatin) 20 mg.

FDA Again Denies Merck’s Request for OTC “Mevacor”

-Congressmen John Dingell (D-MI) and Bart Stupak (D-MI) have requested that the Government Accountability Office (GAO) perform an updated assessment  in response to the US Food and Drug Administration’s potential development of a new class of behind-the-counter (BTC) drugs, according to the Jan. 21 edition of 

In a letter to GAO Comptroller General David Walker, the congressmen requested that more information be gathered in order to assess the benefits, risks, and general necessity of any new class of BTC drugs. In an August 1995 report,  GOA evaluated the experience of other countries with  BTC drugs, and found insufficient evidence  to support the establishment of a new class of BTC drugs in the United States. The US representatives’ letter to  Walker suggested that  the gathering of new data was necessary; however, the new report would not have to include an investigation of other countries with similar BTC drug programs. 

, the potential new class of drugs being evaluated by FDA would be those drugs deemed to not require a doctor’s prescription but would need the approval of a pharmacist to purchase. Although no FDA proposal has been presented regarding the creation of a new class of BTC drugs, opponents suggest the new class may raise drug costs. Supporters of BTC drugs suggest that today’s patients are more informed about their health and that an individual’s access to drugs would improve without the need of a doctor’s prescription.

The potential new class of BTC drugs could include oral contraceptives, over-the-counter children’s cough and cold medicines, Tamiflu, and epinephrine injections.

Rep. Dingell is the Chairman of the House Committee on Energy and Commerce and Rep. Stupak is the Chairman of the Oversight and Investigations Subcommittee.

Congressmen John Dingell and Bart Stupak have requested that the Government Accountability Office perform an updated assessment report in response to the US Food and Drug Administration?s potential development of a new class of behind-the-counter drugs.