Regulatory Reconnaissance (23 October 2012)

Posted 23 October 2012 | By Alexander Gaffney, RAC 

Regulatory Reconnaissance is your daily news recap for the regulatory news and intelligence space. Top stories today include the US Food and Drug Administration's (FDA) approval of a new anti-seizure medication, the start of supplement manufacturing facility registrations under the Food Safety Modernization Act, two legal cases involving FDA, the launch of a huge investigation against Roche by the European Medicines Agency, the appointment of a new vice-chair of CHMP, and a common but potentially dangerous energy drink under fire.

United States

(BioCentury TV) FDA's Director of the Center for Drug Evaluation and Research (CDER), Janet Woodcock, appears on BioCentury This Week to discuss clinical trials, evaluation and how to get products to the sickest patients even faster.

(FDA) US regulators have approved Fycompa (perampanel), an anti-seizure drug manufactured by Eisai Inc. The drug treats the most common type of seizure suffered by patients with epilepsy, and trials showed the drug to be an improvement over existing drug types. The drug's long list of side effects were a concern to regulators, which gave the drug a boxed warning regarding its, "Serious neuropsychiatric events."

(Natural Products Insider) FDA has started, as of 22 October 2012, to accept food facility registration renewals under the Food Safety Modernization Act (FSMA). The Act includes provisions for the registration of facilities that manufacture supplements-a frequent target for FDA regulators in recent months.

(Reuters) Pfizer has agreed to purchase NextWave Pharmaceuticals, a manufacturer of attention-deficit drugs, for $255 million.

(Public Citizen) US advocacy group Public Citizen released a report on 19 October indicating that several of the US's largest pharmaceutical and medical device manufacturers-Bristol Myers Squibb, Eli Lilly, Johnson and Johnson, Merck and Abbott-were among companies giving funds to the US Chamber of Commerce.

(FDA) Regulators released a complete list of all facilities which had received potentially tainted products from the New England Compounding Center (NECC). The list-all 261 pages of it-speaks to the magnitude of the crisis. (See also: Customer List)

(FDA) FDA has released new updates for its Form 356h, used to submit an application to market a new drug, biologic or antibiotic for human use.

(Regulatory Focus) FDA's regulators are stuck in a series of feedback loops that preclude them from taking clear action to help regulate the compounding industry. With good available options lacking, what can FDA do?

(ABC) Compounding pharmacists are working hard to defend their trade in the wake of an outbreak of meningitis that has killed dozens and sickened hundreds. The basic argument: There's a difference between large-scale and small-scale compounding pharmacies.

(NY Times) FDA has long been concerned about compounded drugs, and in particular about their sourced components, which are increasingly coming from unknown sources abroad.

(Reuters) The number of patients made ill by fungal meningitis is now up to 297, and is still increasing every day.

(FDA) FDA has entered into the Federal Register the list of all animal drug products approved during the month of September 2012.

(Regulatory Focus) FDA won a case against ISTA Pharmaceuticals after the judge slammed the company for making claims thinly sourced in the truth…

(Regulatory Focus)…but lost another, and was ordered to approve an abbreviated new drug application filed by Watson Laboratories that will complete against Takeda's diabetes drug Actos.


(Regulatory Focus) EMA has launched an investigation into Roche for massively underreporting adverse events made against 19 of its pharmaceutical products. If found guilty, the company could be forced to surrender 5% of its yearly revenue.

(Regulatory Focus) The Committee on Medicinal Products for Human Use (CHMP) has appointed a new vice-chair after its previous one was appointed chair in the wake of a scandal.

(Fierce Pharma) Draft trade agreements in the works between Canada, Europe and Israel could see all three economic areas adopting 10-year patent protections for pharmaceuticals-a two-year premium over Canada's eight years of protection. (See also: Pharmalot)

(Health Canada) Canadian regulators have opened a consultation on a draft guidance on good manufacturing practices for active pharmaceutical ingredients. The guidance, released in late September 2012, is open for 75 days of public comment. The comment period closes on 5 January 2013.

(MHRA) The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation on the planned introduction of some new fees and modified fee levels intended for medicinal products. The consultation ends 30 November.

(MHRA) MHRA is preparing to hold a Pharmacovigilance Symposium in 2013 for members of industry and academia who wish to learn how to avoid common deficiencies.

(MHRA) Bard Ltd Is being hit with a recall after plastic particles were observed in several of its catheter devices. Regulators warned that the plastic particles could be transferred to the patient in certain circumstances.

(Pharmalot) Sanofi is under fire in the UK for a program critics say is a shameless attempt to increase the price of a multiple sclerosis drug fourfold by removing an alternate-and cheaper-version of the drug from the market. While the company has instituted a patient assistance program, public outcry threatens to undo its goodwill efforts.

(Nature) Does Health Canada's new clinical trials registry proposal have enough "teeth?" Not according to some critics, reports Nature. Those critics were most dismayed at the initiative's lack of disclosure for all clinical trials data, which they contend should be publicly available to inform patients about the true risk of a drug, which are sometimes discovered but never released to the public.

(PharmAfrica) Africa is in the midst of a continent-wide regulatory harmonization effort meant to better utilize its limited healthcare resources. With the help of a grant from the Bill and Melinda Gates foundation, the Global Medicines Regulatory Harmonization (GMRH) and the African Medicines Regulatory Harmonization (AMRH) are both working to share information and initiate regional planning efforts.

(Regulatory Focus) India's Central Drugs Standard Control Organization (CDSCO) has finalized a good distribution practice guideline, which has now come into effect.

Essential Reading

(Forbes) Patients prescribed Warfarin are highly likely to discontinue using the drug, with 61.3% of all patients discontinuing its use within five years. Nearly 10% never file a second prescription.

(Forbes) It's sometimes difficult to remember that caffeine is a drug. But FDA's 22 October announcement that energy drink manufacturer Monster's energy drink line has been associated with at least five deaths seems likely to remind patients of the dangers of overdosing on caffeine. It certainly reminded investors-the company's stock was down substantially after FDA's announcement.

(RxTrace) Is the way FDA recalls products overdue for an overhaul? Likely so, but it will take the cooperation of industry and some common-sense standardization, argues Dirk Rogers.

(Harvard Bill of Health) As the internet and social media channels change the way we view and define the right to privacy, are Institutional Review Boards (IRBs) overestimating the potential for harm when patient data is transmitted to clinical trials participants digitally?

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