Associated Press: FDA Announces Plans to Improve Public Announcements on Food, Drug Safety

The Associated Press on September 30, 2009 reported, "The Food and Drug Administration is laying out plans to improve its public announcements on food and drug safety, more than three years after federal advisers recommended major changes." The agency "will begin studying public response to its announcements on potentially dangerous food and drugs."

Given the recent proliferation of counterfeit, adulterated, fraudulent and production issues on medications and consumer products produced and distributed in the United States, this is announcement is seen as an important step forward in protecting the domestic consumer.

Caraco: FDA to Eventually Allow Manufacturing Operations

The Associated Press and several major news outlets reported that Caraco Pharmaceutical Laboratories announced on Tuesday that it has agreed to a series of measures with the FDA that will allow the company to resume manufacturing operations.

As reported on Secure Pharma Chain Blog, Caraco has had their manufacturing operations halted by the FDA after they found repeated violations of manufacturing standards and seized inventories. Recalls have been made on certain Caraco products that were found to have manufacturing defects, including oversized tablets and possible formulation errors.

The manufacturing restrictions will be in place until regulators give written notification of compliance with the agreement measures and regulations. Caraco will continue to distribute FDA-approved products manufactured by third parties.

XStream endorses the concept that all members of the pharmaceutical supply chain utilize material screening process in all points of the process; raw materials, production, quality assurance, packaging, distribution and dispensing in order to protect the supply chain and the consumer.

To learn more about XStream’s revolutionary material screening technology visit: www.xstreamsystems.net.

K-V Pharma: FDA Accepts Plan to Resolve Manufacturing Issue

Reuters on September 2nd reported that K-V Pharma has announced that the U.S. Food and Drug Administration had accepted its work plan to address previously identified deficiencies in its manufacturing practices. In March, the U.S. Department of Justice sued the drugmaker to block it from making and distributing adulterated and unapproved drugs, after an inspection by the FDA found the company had violated manufacturing guidelines and continued to manufacture unapproved drugs.

K-V Pharma has begun implementing certain measures set forth in the work plan but does not expect to resume product shipments before the third quarter of fiscal 2010, it said in a filing with the U.S. Securities and Exchange Commission on Wednesday.

The drugmaker said it anticipates it will request Lachman Consultants, its independent current good manufacturing practices (cGMP) expert, to conduct its certification review later this calendar year.

To view entire article visit: www.reuters.com.

FDA Highlights Agency’s Plans for 2010

The FDA has some interesting plans for 2010. According to FDAnews here are a few highlights of the agency's plans:

• More than double the number of drug import field examinations
• 346 new hires for the signature Safer Medical Products initiative
• A 43 per cent increase in foreign GMP surveillance inspections
• New field offices in New Delhi, Beijing, Shanghai, Mexico, Costa Rica and other overseas hot-spots, manned by at least 60 staffers

Although XStream is supportive of increased enforcement and inspection, we encourage all commercial members of the pharmaceutical supply chain to increase their screening, verification and authentication of materials and products. Protecting your brand beyond regulatory enforcement is the key to success and avoidance of catastrophic failures within the supply chain.

Caraco to Eliminate Nearly 350 Employees Due to FDA Seizures

Caraco Pharmaceutical Laboratories has announced that it will eliminate approximately half of its employees and curb overhead by suspending all manufacturing following the seizure by the US Food and Drug Administration (FDA) of up to 33 of the company's generic drugs due to manufacturing violations. This is anticipated to impact over 350 employees.

In June 2009 the FDA seized drugs made at the company's Michigan facilities in Detroit, Farmington Hills and Wixom. The seized drugs included generic versions of heart, pain and psychiatric drugs as well as the epilepsy treatment Tegretol and a generic copy of the diabetes drug Glucophage.

Earlier in 2009 Caraco had been charged with repeated violations of FDA’s current Good Manufacturing Practice (cGMP) requirements. Beginning in January 2009, Caraco initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.

XStream Systems endorses the concept of material screening of pharmaceuticals from raw materials, through the various points of production, within the distribution supply chain and at the point of dispense.

Validation at all points of the pharmaceutical supply chain from the manufacturer to the consumer verifies quality and protects against counterfeiting, fraud and adulteration.

Considering the Source – WHO cracks down on GMPs of their suppliers BIG and small.

The finished product is only as good as the sum of its parts.

We are seeing a trend of stricter enforcement of Good Manufacturing Practices (GMPs). Even larger pharmaceutical manufacturers are feeling the pinch as the quality of their pharmaceutical ingredient suppliers are put to the test.

Recently The World Health Organization (WHO) announced they would suspend tuberculosis drugs from Wyeth Pakistan because they questioned the quality of the drug. Their shift in trust of the finish product stemmed from a switch in suppliers for one of its ingredients. The outsourcing of ingredients has become a challenge for manufacturers because consistent suppliers are not always accessible.

A summary of the article appears below and you can view the entire article at American Enterprise Institute website at: www.american.com.

Consider the Source
(Tuesday, May 19, 2009; by Roger Bate; Journal of American Enterprise Institute)
A recent case reveals that it is not only generic firms from middle-income countries that have problems with good manufacturing practice.

The World Health Organization (WHO) late last month announced it was suspending approval for all tuberculosis drugs produced by the Pakistan plant of a subsidiary of the U.S. drug company Wyeth, because it was “no longer assured of the quality of the product.” The drugs had been approved by WHO, which UN agencies, national governments, and other international organizations use to guide the procurement of millions of dollars of HIV/AIDS, malaria, and tuberculosis drugs for the world’s poorest patients.

According to a letter to the company posted on WHO’s website, Wyeth failed to inform WHO that it had changed suppliers for some of its active pharmaceutical ingredients (API) and had altered storage conditions. “They had been informed on a number of occasions”—directly and through communications to all suppliers—“about the importance of informing WHO,” Matthias Stahl, medical officer in charge of assessments at WHO’s drug approval program, told us. WHO’s most recent inspection of the site, in 2005, identified serious noncompliance with Good Manufacturing Practice (GMP), and since that time only limited corrective action had been taken.

The case reveals that it is not only generic firms from middle-income countries that have problems with GMP, as we have previously discussed regarding India’s largest drug company Ranbaxy. Wyeth and Ranbaxy, which are both reputable companies, will probably resolve their particular problems soon. But as more firms source more intermediate chemicals and API from myriad countries, we may be seeing the beginning of a trend.

XStream Systems understands this dilemma. A solution that addresses brand protection and integrity is the use of EDXRD technology for molecular pharmaceutical authentication. By screening products throughout the supply chain, authenticity and quality issues can be addressed on the spot before ever reaching the consumer. To learn more of this technology and how it can help visit: www.xstreamsystems.net.