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Last week, I reported in a post that in 2011 the US Food and Drug Administration (FDA) had approved a near-record of 35 new medicines. Coincidentally, earlier this week, Ed Silverman posted on the Pharmalot blog that prescription drug recalls are rising and nearing historical records. 

According to Ed, “During the third quarter of this year, the number of pharmaceutical recalls jumped to 150, compared with about 90 recalls during each of the first two quarters of 2011, according to FDA Enforcement Reports. Moreover, the recent tally dwarfs the roughly 65 recalls that were made during the last quarter of 2010 and nearly doubled the 80 recalls that were notched during the 2010 third quarter.”

The reason for the spike in drug recalls? Some suggest that FDA is getting tough and still trying to reinvent itself after the 2004 Vioxx debacle and the tainted heparin incident. Also, Congress is putting pressure on the agency to better enforce manufacturing regulation and supply chain management practices. Sadly, the only way for FDA to accomplish this is by increasing the number of inspections that it conducts on both foreign and domestic manufacturing facilities. And, given that the agency’s budget for enforcement activities has not increased much over the past few years; it is unlikely that increased regulatory scrutiny will occur any time soon.

Finally, for those of you who may not know. FDA does not have the authority to recall drugs. Recalls are voluntary and must be orchestrated by the company that manufactures the product in question. Luckily, FDA has many financial and legal methods at its disposal to induce companies to “voluntarily” recall suspect or tainted products from the US market.

Until next time...

Good Luck and Good Job Hunting!!!!!!

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Last week, the US House of Representatives voted to cut FDA funding by $220 million. The House vote was not surprising given the prevailing attitude among many pharmaceutical and biotechnology company executives that FDA approval of new drugs and devices has become increasingly difficult. While there is no question that the current approval process for new drugs and devices has become more rigorous as compared with the incredibly lax process (and in some cases, the almost non-existent process) used during the Bush Administration, the FDA is simply fulfilling the mandate for the agency when it was created in 1938. That is: to provide the American public with SAFE and efficacious drugs to treat unmet medical need. 

Until recently, the FDA had been chronically under funded. And, because of this, the American public was forced to suffer through the Vioxx scandal, the heparin scare and the appearance on the market of many unapproved medical devices. These and other events that occurred over the past decade beg the question: “Should the American public’s safety be placed in jeopardy again simply because the Republican-controlled House is looking for ways to cut deficit spending?”

Unfortunately, the activity of anti-FDA lobbyists (funded mainly by US pharmaceutical and biotechnology companies) has been ramped up ever since the Democrats lost control of the House. And, since most Republicans believe that any government regulation whatsoever is too much regulation, it is easy to understand the House would vote to cut FDA funding. Nevertheless, insufficient funding will not allow the agency to hire the number of inspectors required to insure that drug manufacturing is conducted according to FDA-mandated regulatory guidelines. These activities are essential to insure the safety of the prescription drugs and medical devices sold on the US market.

According to FDA Current Good Manufacturing Practice (CGMP) guidelines, drug manufacturing plants for all approved drugs and devices are to be inspected every two years. Inspections are required for all manufacturing plants in the US as well as FDA-approved manufacturing facilities overseas. Because of ongoing shortages of FDA inspectors (and the emergence of numerous overseas manufacturing facilities), these inspections are typically conducted every three to five years rather than every two years! Clearly, this is not in the best safety interests of the American public.

A report published by the General Accounting Organization about the heparin scare of three years ago nicely sums up the issues.

“In its response to the heparin crisis, FDA took several actions related to its responsibility to protect the public health by ensuring the safety and security of the nation’s drug and medical device supplies. FDA increased its activities related to oversight of heparin firms by conducting inspections and investigations and monitoring heparin imports, and worked with drug and device manufacturers to recall contaminated products while ensuring that an adequate supply of uncontaminated heparin was available. With the help of external entities, FDA identified the unknown contaminant and developed tests to screen all heparin products. Additionally, the agency reached out to its international regulatory partners during the crisis. However, FDA faced some limitations in its efforts to inspect heparin firms in China and collaborate internationally, and the agency was unable to determine the original source of contamination.”

Interestingly, as today reported by the EyeonFDA blog, the U.S. House of Representatives Energy and Commerce Committee announced today that it was re-opening examination of the heparin contamination issue.  A letter was sent by the Chair of the Committee, Rep. Fred Upton (R-MI) as well as other members to FDA Commissioner Margaret Hamburg requesting that the agency supply all documents in connection with the heparin investigation from January 1, 2008 until present.  In its announcement, the Committee stated:

“It has been almost three years since the FDA linked deaths and serious allergic-type reactions of patients in the United States to supplies of heparin that came from the People’s Republic of China which was adulterated with overly sulfated chondroitin sulfate (OSCS). FDA officials believe this was an instance of economically motivated adulteration,” the members wrote. “However, neither the Chinese government nor the FDA has identified those responsible for the contamination or described how the heparin actually came to be contaminated.”

Mark Senak, author of  EyeonFDA blog aptly noted:

"It is certainly important in that any public health crisis involving the contamination of food or drugs be thoroughly investigated. But the investigating body can’t have it both ways. You can’t criticize an agency for not conducting inspections that are not funded by the same members of the same investigative body."

Is this any way to run a country?

Until next time...

Good Luck and Good Job Hunting!!!!!!!

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For the past year or more, the US media has been vociferously bashing tainted imported Chinese goods any time it can. The tainted products have ranged from toys to dog food and most recently to Baxter’s heparin which has been associated with illnesses and deaths in this country.  

I suspect that this recent spate of China bashing has more to do with political and future economic issues than the safety and well being of the American public. Nevertheless, according to US Food and Drug Administration Current Good Manufacturing Practices (CGMP) regulations, companies that hold the licenses to manufacture pharmaceutical and biotechnology products assume full responsibility for the quality and safety of their products. To accomplish this, companies are required to test all raw materials, excipients and APIs (regardless of their source) before they are assembled to make a finish pharmaceutical or biotechnology product. The results of these tests must be carefully analyzed and compared with the product quality specifications established by the company and approved by FDA. If the test results for product ingredients are outside of the normal range of established specifications, then the company is obliged to reject the materials and not used them to manufacture product. To that end, there was clearly, something was wrong with quality testing at the Baxter heparin manufacturing facility because the adulterated heparin API should have been detected long, before it was used to manufacture the final product. Although the Chinese heparin may have adulterated, the onus was on Baxter (the company that holds the product license) and not the Chinese government to insure its final product met quality standards and was safe for public use.

Outsourcing is a fact of life in almost every sector of the American economy. Pharmaceutical and biotechnology companies import the materials they use in their products from all over the world. It is FDA’s job to insure that American companies remain CGMP compliant so that they produce safe and effective medications. To blame America’s regulatory shortcomings on foreign manufacturers and their governments is dangerous and naïve-not to mention chauvinistic.

Until next time…

Good Luck and Good Job Hunting (try Shanghai)!!!!!!!!!!

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