Regulatory Focus™ > News Articles > Regulatory Reconnaissance (24 October)

Regulatory Reconnaissance (24 October)

Posted 24 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) release of new user fee guidance for generic drugs, the launch of a new data standards program, the release of a new batch of FDA warning letters, the signing of several trade deals, Greece's decision to ban pharmaceutical exports, and why most of the headline-grabbing studies you read are probably wrong.

United States

(Regulatory Focus) FDA has released guidance on the fees it will assess for new and existing generic drug applications.

(Regulatory Focus) FDA, CDISC and C-Path have all announced the launch of a new data standards group named C-FAST. The partnership is intended to harmonize clinical data standards for more areas.              

(Regulatory Focus) FDA's Drug Safety and Risk Management Advisory Committee is looking to reassess REMS for teratogenic products. Of particular interest: reforming the way FDA requires the use of birth control and pregnancy testing for women taking such drugs.

(Eye on FDA) The number of untitled letters sent by FDA during 2012 has thus far been below the pace of either of the two preceding years, noted Mark Senak of Eye on FDA. The majority of such letters were aimed at communication problems, usually with marketing vehicles and problems with risk communication or the overstatement of efficacy.

(House) Legislators are taking aim at the New England Compounding Pharmacy, the company whose products are now linked with an outbreak of fungal meningitis. In a letter sent to the company and its executives on 22 October, the House Energy and Commerce Committee said it was seeking all reports, documents and analyses conducted by the company. The committee has previously made a similar request of FDA. (Read more: The Hill)

(FDA) The regulatory crackdown on cosmetic manufacturers continues this week, with yet another cosmetic manufacturer, Skin Biology Inc, receiving a warning letter from FDA regarding improper marketing claims.

(Fierce Biotech) FDA rejected United Therapeutics' oral pulmonary arterial hypertension (PAH) drug, issuing a complete response letter after finding weaknesses in the company's supporting data, reports Fierce Biotech.

(FDA) It was a quiet week for FDA warning letters, but several other ones caught Regulatory Focus' eye: Alere Inc (Medical Device) for deficiencies related to its Triage brand cardiac marker devices, Primus Medical (Medical Device) for adulterated devices, Global Medical Holdings (Medical Device) for CGMP deficiencies,  Garlic Wise (Supplement) for marketing itself as an unapproved drug, and Quincy Bioscience Manufacturing (Supplements) for… pretty much everything.

(The Pink Sheet) Risk Evaluation and Mitigation Strategies (REMS) were instituted in 2007 as a way to protect patients from potentially unsafe drugs by allowing FDA to require special access plans and other restrictions to keep access to products limited. But with the number of generic firms now being thwarted by plans meant to protect patients, is it time to tweak the REMS program? (Subscription)

(The Pink Sheet Daily) An overwhelming number of comments in the federal register support CDISC's data standard, the Operational Data Model, instead of the Health Level 7 standard sought by some other stakeholders. (Subscription)

(Time) Whole Genome Sequencing (WGS) is becoming increasingly affordable thanks to improvements in technology, but the sector is also coming increasingly amount of regulatory scrutiny from FDA and others as officials considering requiring approval for the products. Does such oversight risk putting their services out of reach for patients, or is the sector overdue for basic oversight?

(FDA) US Marshals moved on Tuesday, 23 October to raid a dietary supplement manufacturer which FDA officials said had flaunted its regulators since at least 7 July 2011 when the agency sent New York-Confidence Inc a warning letter. FDA said the company did not manufacture its products according to federal law and marketed a number of its drugs as treatments for specific diseases.

(Regulatory Focus) That 2011 warning letter to Confidence Inc is similar to one sent in October 2012 to supplement manufacturer Advanced Nutritional Technology Inc, which was also accused to violating CGMP and marketing regulations by FDA.

(Regulatory Focus) New facility registration requirements have come into effect for supplement manufacturers, processors, packagers and storage facility owners. The requirements are outlined in a new guidance for industry released by FDA on 22 October.

(FDA) Need to learn more about Risk Evaluation and Mitigation Strategies (REMS)? FDA is hosting a webinar on 30 October 2012 on the subject.

(White House) The US has finalized its trade agreement with Panama and is now just waiting for the entry-into-force date. The agreement was signed on 21 October by President Obama.

(Natural Products Insider) Dietary supplement trade groups want FDA to revise its position on synthetic botanicals, which FDA maintains are not supplements because they are effectively drug products. The Council for Responsible Nutrition said FDA's position was contrary to the law and to the public interest.

(Open Secrets) Presidential contributions from pharmaceutical companies tend to be skewing-58% to 425-toward Mitt Romney…

(Open Secrets) … While Medical Device manufacturers skew for Republicans 60/40%.

(Regulatory Focus) FDA's compassionate use program is increasingly being used, and experienced 20% growth from 2010 to 2011, reports The Wall Street Journal.


(Pharma Times) The European Commission (EC) has announced the launch of new rules for the import of active pharmaceutical ingredients (APIs). Imported products must meet the same good manufacturing standards as APIs originating from the EU. (Europe)

(EuroParl) The European Parliament has approved a trade deal with Israel that would allow EMA-approved drug products to be exported to Israel without further certification requirements, and visa-versa. The deal was held up for years due to concerns about Israel's treatment of Palestinians, the parliament said in a statement. (Europe / Israel)

(PharmExec) The forced exit of John Dalli from the European Commission (EC) has brought a harsh spotlight to EU regulators, who have not had an easy or low-profile year as it is, notes PharmExec.

(Reuters) Italy's health ministry has issued a ban on four of Novartis' influenza vaccines after deciding to require further testing to assess the product's safety profile. (Italy)

(The Guardian) Should anti-malarial drugs be available to consumers over the counter (OTC) in Africa, or does this risk the proliferation of sub-standard or fake drugs? The argument has engrossed the global aid community, reports The Guardian. (Africa)

(Health Canada) Canadian regulators want feedback on four new herbal monographs released for consultation. (Canada)

(MHRA) UK regulators are just as interested in making sure you know what not to send them as what you should, and have provided some basic guidance for industry on this page. (UK)

(Daily Mail) A UK legislator is calling for the publication of all clinical trials data by pharmaceutical companies. The member of parliament says hidden trials data has the potential to harm patients and waste taxpayer funds, reports The Daily Mail. (UK)

(PharmAfrica) Nigeria has set a deadline for all antibacterial products to contain a scratch-and-text label aimed at combating counterfeit products that leech off the legitimacy of other established products. (Nigeria)

(ANSM) France has released a report detailing that state of its industry in 2011. Highlights: the share of generics prescribed in France has fallen 1.3%, and ANSM re-evaluated the risk-benefit balances of many specialty areas and therapeutic classes. (France) (In French)

(Regulatory Focus) Greece has banned the export of all drugs after being hit with huge shortages resulting from price arbitrage across the EU. (Greece)

Essential Reading

(Regulatory Focus) Regulatory bodies should pay more attention to efforts to build regulatory capacity around the world, argue three of FDA's top international regulatory officials.

(NPR) An analysis of 85,000 studies-yes, you read that number correctly-has found that roughly 90% of all studies showing a large treatment effect are later found to have a substantially smaller effect. The takeaway: the public and scientists alike needs to be more cautious about interpreting research and drawing broad-based conclusions from impressive-looking but small-scale research. (More: Medscape, Med Page Today)

(Reuters) The development of medical guidelines are non-standard and are not subject to any form of quality control or consistent oversight. Now some experts are asking whether the development of such guidelines should be required to meet basic quality guidelines.

(CNN) The fiscal cliff may not be a regular topic of discussion in some circles, but it's still scheduled to come into effect in January, and it could have a catastrophic effect on the economy.

(MDDI) Medical device software is an under-appreciated and oft-overlooked component of the device development process. Give it more respect and attention, argues Malinda Elein.

(PLoS) What are the ethical implications of conducting research using online communities as a data source? Essentially the same as any other study, argues a group of researchers in the Public Library of Science.

(Med City News) Stephanie Baum assembles four anticounterfeit startups worth knowing. Among their technologies: imprinted packaging codes, embedded tags made with inactive ingredients, scratch-off text codes and IR fingerprinting.

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