Angie Drakulich was editorial director of Pharmaceutical Technology.

Angie Drakulich

The US Department of Health and Human Services (HHS) will send the first US Food and Drug Administration staff to China, India, Europe, and Latin America before the end of 2008, HHS Secretary Mike Leavitt announced last week in a press release.

 “We’re making steady progress to better safeguard our supply of food and medicines, though much work remains,” said Leavitt. “In the past year, we’ve upgraded labs and equipment, hired additional staff, and begun implementing product safety agreements with key trading partners, including China.”

The move to expand staff presence abroad, especially in China, comes after a year of negative reports regarding contaminated products and drugs with ties to Asia. Baxter Healthcare’s (Deerfield, IL) heparin was contaminated with chondroitin manufactured at the Changzhou SPL plant in Changzhou, Jiangsu, China. Toothpaste and pet-food products manufactured with ingredients from China were determined to be contaminated with melamine in 2007, and, more recently, milk products from China have been found to have melamine in them as well. In India, FDA issued an Import Alert last month for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants  due to good manufacturing practice violations.

 “Increasing our presence overseas will provide greater protections to American consumers at home and benefit our host countries as well,” said Leavitt in the press release. 

FDA Commissioner Andrew C. von Eschenbach added that the agency’s new Beyond our Borders initiative, established in March 2008, means FDA “won’t have to send our experts to another country to work with foreign governments and regulated industry to improve our oversight-we’ll have staff living there and working on the ground 365 days a year.”

According to the press release, the first overseas office will be in China with the first staff in place in Beijing before the end of the year. Additional staff will be posted in 2009. Staff will also be based in Shanghai and Guangzhou starting next year, for a total of eight US nationals in China.

Plans for a second overseas office will follow in the Republic of India, with the first staff arriving in New Delhi in 2008 and at least one additional office to follow in 2009. A total of 10 US nationals are expected to be based in India.

HHS/FDA offices are also planned for Europe and Latin America before the end of 2008, and a fifth office in the Middle East will be established in early to mid-2009.

 “Previously, federal officials relied extensively on inspections at the border to ferret out unsafe goods, an approach that has not kept up with the exponential growth in global commerce,” says the press release.

 With the new offices intact, US personnel will work closely with local authorities and industries that ship food and medical products to the US, according to the press release. Their activities will include “providing technical advice, conducting additional inspections, and working with government agencies and private sector entities interested in developing certification programs.”

 For more information, visit HHS’s Import Safety Action Plan site at 

Articles

The US Department of Health and Human Services (HHS) will send the first Food and Drug Administration staff to China, India, Europe, and Latin America before the end of 2008.

HHS to Open Offices Abroad, Starting with China

 reported that the US Food and Drug Adminstration had 

of fluoroquinolone antimicrobial drugs to add a black-box warning label on their products noting the increased risk of tendonitis and tendon rupture with the drug’s use. Also in July, the European Medicines Agency (EMEA) had 

  strengthening the warnings for oral moxifloxacin medicines and concluded that these drugs should only be prescribed to treat acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and community-acquired pneumonia when other antibiotics cannot be used or have failed.

Now, three months later, FDA has completed its labeling updates. The agency posted the new labels on its website last week. 

Affected drugs include: “Cipro” and generic ciprofloxacin, “Cipro XR” and “Proquin XR” (ciprofloxacin extended release), “Factive” (gemifloxacin), “Levaquin” (levofloxacin), “Avelox” (moxifloxacin), “Noroxin” (norfloxacin), and “Floxin” and generic ofloxacin. 

FDA has completed its labeling updates to fluoroquinolone antimicrobial drugs.

PharmTech Followup: Fluoroquinolone Antibiotics

 has been covering the US Food and Drug Administration’s rulemaking on over-the-counter (OTC) cough and cold medications for children. In January 2008, the agency issued a Public Health Advisory recommending that these drugs not be used to treat infants and children under the age of 2 because serious and potentially life-threatening side effects can occur. Wyeth (Madison, NJ), Prestige Brands (Irvington, NY), Johnson & Johnson (New Brunswick, NJ), and Novartis (Basel) voluntarily withdrew related medications for children under age 2 in October 2007. (See "

Public Comment on Cough and Cold Meds for Kids

 On Oct. 2, 2008, FDA held a public meeting to discuss cough and cold medications for pediatric use before it finalizes a proposed rule to revise the pediatric labeling contained in the "Final Monograph for Cough, Cold, Allergy, Bronchodilator, and Anti-asthmatic Drug Products for Over-the-Counter Human Use." 

Last week, the president of the Consumer HealthCare Products Association (CPHA), Linda Suydam, issued a 

  saying that “children’s over-the-counter (OTC) cough and cold medicines are safe and effective when used as directed” and that “research shows that dosing errors and accidental ingestions-not the safety of the ingredients themselves when properly dosed-are the leading causes of rare adverse events in young children.”

The statement went on to report that the “leading manufacturers of these medicines are voluntarily transitioning the labeling on oral OTC pediatric cough and cold medicines to state ‘do not use’ in children under four years of age.” For products containing certain antihistamines, manufacturers are voluntarily adding new language that warns parents not to use antihistamine products to sedate or make a child sleepy, said Suydam. The changes will take place throughout the 2008–2009 cough and cold season. Additional dosing device changes and packaging may be coming as well to help reduce dosing errors with these medications, according to the CPHA statement.

FDA responded to CPHA's statement on Oct. 8, 2008, with its 

 on OTC pediatric cough and cold medications. "Although this new labeling is inconsistent with the current monograph, FDA will not object, under the circumstances presented here, to the new label modification stating 'do not use in children under 4,' which reflects a more restrictive use of the drugs in children. The steps that are being taken by CHPA will not affect the availability of the medicines, but this voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others."

The agency says it will continue to work with the Centers for Disease Control and Prevention to monitor the ongoing use of cough and cold medications for children and to develop educational materials for parents and consumers. FDA also plans to continue to reach out to the scientific community to obtain  up-to-date information and scientific data about the effects of these products in children, with future regulatory steps in mind.

During the past several months, Pharmaceutical Technology has been covering the US Food and Drug Administration's rulemaking on over-the-counter (OTC) cough and cold medications for children.

PharmTech Followup: Pediatric Cough and Cold Medicines

The lack of appropriate financial resources for the US Food and Drug Administration’s growing global agenda has been a pertinent topic of late-and now appropriate staffing has become a large concern. Specifically, criticism has mounted regarding the way in which FDA recruits individuals to its advisory committees and the fact that some members have conflicts of interest.

 from the Government Accountability Office (GAO), 

FDA Advisory Committees: Process for Recruiting Members and Evaluating Potential Conflicts of Interest

,  found that “FDA employed many of the same recruitment and evaluation practices used by organizations previously identified by GAO as employing methods that could ensure an independent and balanced advisory committee.” 

That said, those interviewed in the GAO report said FDA faced barriers when it came to recruiting qualified advisory committee candidates without potential conflicts of interest,  GAO found that “the agency may have been able to mitigate these barriers by expanding its outreach efforts.” The problem, as identified by GAO, was that the individuals FDA sought for its committees were “the same leading experts that industry sought to conduct research.” 

The US Senate requested the GAO report, which was based in part on interviews with FDA, former advisory committee members, and members of the Pharmaceutical Research and Manufacturers of America (PhRMA). Focusing on the agency’s advisory committee process, GAO looked at: (1) how FDA recruits individuals for membership and evaluates candidates for potential conflicts of interest, (2) barriers for recruiting qualified individuals to serve on committees, and (3) the proportion of standing and temporary members, and the frequency with which members with conflicts of interest participate in meetings. 

GAO reported that more than half of the meetings it reviewed had “at least one standing or temporary member with at least one conflict of interest determination.” This represented about 16% of all 83 meetings’ participants. 

GAO was unable to examine the effects of changes in FDA’s advisory committee processes resulting from the FDA Amendments Act of 2007 (FDAAA) and 2007 FDA policy revisions as it was too soon to assess them, states the report. 

Whether or not the FDAAA will any impact on recruitment or conflicts of interest remains to be seen. Meanwhile, FDA’s overall staffing has lead to delays in several drug reviews. The agency announced that it will miss the Prescription Drug User Fee Act (PDUFA) deadline for Takeda’s (Tokyo) new drug application for alogliptin, a Type 2 diabetes drug. 

 FDA missed PDUFA review deadlines for Amgen’s (Thousand Oaks, CA) “Nplate” and GlaxoSmithKline’s (London) “Promacta” earlier this year.

The lack of appropriate financial resources for the US Food and Drug Administration's growing global agenda has been a pertinent topic of late?and now appropriate staffing has become a large concern.

FDA's Recruitment Troubles Real

The US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) held a public meeting on Oct. 2, 2008, to discuss over-the-counter (OTC) cough and cold medications for pediatric use. The agency has been reviewing these particular drugs since the American Academy of Pediatricians and other groups began calling for a ban on cough and cold medications for children under age 6, based on  studies that show no health benefit to this age group.

Despite reiterated calls during the meeting for an immediate ban on such medications for young children, Dr. John Jenkins, head of FDA’s Office of New Drugs, rejected the idea, according to 

. He said such a ban might lead to an even worse situation in which parents offer their children adult medications. But the agency did not dismiss the concerns regarding these drugs. 

FDA officials said that they were still not comfortable with the lack of solid scientific data to support the continued use of OTC cough and cold remedies for children between the ages of 2 and 6, reports 

. When the agency set standards for cough and cold medicines nearly 30 years ago, they were based on adult-only studies. Studies show that these drugs are not effective in young children. 

 “When a treatment is ineffective, its risks-unless zero-always exceed its benefits,” said Dr. Michael Shannon of Boston’s Children’s Hospital, according to 

 FDA advised last spring that the medications not be used for children under 2, but has not made a similar recommendation for children  between age 2 and 6. The agency now plans to decide by spring 2009 what to do about these drugs for children younger than age 11.

 Meanwhile, parents are left wondering what to do as another winter season approaches. Most doctors, says 

, suggest rest and plenty of fluids help to clear up a cold. 

The US Food and Drug Administration?s Center for Drug Evaluation and Research (CDER) held a public meeting on Oct. 2 to discuss over-the-counter (OTC) cough and cold medications for pediatric use.

Decision Delayed for Pediatric Cough and Cold Meds

The electronic pedigree mandate for prescription drugs has been delayed again. California Gov. Arnold Schwarzenegger signed legislation that delays ePedigree implementation until 2015. 

The deadline was first pushed back last March, from January 2009 to January 2011. Now, manufacturers will have another few years to comply with the new requirement.

Under the act, S.B. 1307, a manufacturer selling drugs in California must have an ePedigree for 50% of the drugs it sells in the state by 2015. As of July 2016, wholesalers or repackagers will be prohibited from selling, trading, or transferring a dangerous drug without a pedigree or from acquiring a dangerous drug without receiving a pedigree; the same rule will go into effect for pharmacies in July 2017. A pharmacy warehouse will not be able to acquire a dangerous drug without receiving a pedigree, as of July 2017.

Industry has been keeping an eye on California’s ePedigree rules as they are likely to impact all US manufacturers and set the stage for a national ePedigree standard. It now looks like companies have more than enough time to prepare. 

Epedigree in the Pharmaceutical Supply Chain

The electronic pedigree mandate for prescription drugs has been delayed again. California Gov. Arnold Schwarzenegger signed legislation that delays ePedigree implementation until 2015.