Regulatory Focus™ > News Articles > Regulatory Reconnaissance (6 November)

Regulatory Reconnaissance (6 November)

Posted 06 November 2012 | By Alexander Gaffney, RAC

Regulatory Reconnaissance is your daily news recap for the regulatory news and intelligence space. Top stories today include plans for US Food and Drug Administration (FDA) Commissioner Margaret Hamburg to appear before a House committee, an untitled letter sent to the Burzynski Clinic, seven new documents from the now-defunct Global Harmonization Task Force, calls for a new clinical trials framework in Canada and some keen insight on FDA warning letters from two industry watchers.

United States

(Reuters) The House Energy and Commerce Committee has scheduled two hearing over the meningitis outbreak scandal, and has called upon FDA Commissioner Margaret Hamburg to testify. The Senate's Health, Education, Labor and Pensions (HELP) Committee has scheduled a similar hearing, though Hamburg is not scheduled to attend.

(Med Page Today) FDA reviewers have called Signifor (pasireotide) effective at treating Cushing's disease. The drug, manufactured by Novartis, is set to go before FDA's Endocrinologic and Metabolic Drugs Advisory Committee on 7 November 2012.

(NY Times) PCSK9 inhibitors are shaping up to be some of the hottest and most promising new drugs for lowering cholesterol. The New York Times' Andrew Pollack explores the race to replace expired drugs like Lipitor.

(FDA) Federal regulators have warned a Tennessee company for marketing a light therapy medical device that it claimed could treat fungal meningitisis, MRSA, Lyme disease and other ailments.

(USP) The US Pharmacopeial Convention (USP) has announced a change in the labeling requirement for Heparin to clarify the expression of dose.

(FDA) The Office of prescription Drug Promotion (OPDP) has finally put its foot down against the Burzynski Clinic-a treatment center that claims to heal patients using antineoplaston-based therapy. The clinic has been operating a series of clinical trials for decades, and OPDP said the clinic's investigation new drug application (IND) does not permit it to market the therapy as it has been. (The clinic's marketing materials)

(FDA) Another OPDP untitled letter to ONY, Inc claims the company's Infasurf product is being marketed using false or misleading claims based on its superiority claims. (Marketing materials)

(MDDI) FDA's new Unique Device Identification (UDI) rule has come under some industry scrutiny as of late. The most recent, explains MDDI's Jim Dickinson, is the standardized date format.

(Brookings) Not sure what the UDI is? Think tank Brookings Institute has a 90-minute presentation on the value it is set to provide to healthcare systems and providers.

(The Pink Sheet Daily) Amgen was before the Supreme Court yesterday posing a bright-line question for the justices: What, exactly, constitutes securities fraud?


(GHTF) The Global Harmonization Task Force (GHTF) has held its last meeting ever, and has released at least seven new final documents. They are listed below:

(Pharma Times) The Canadian legislative is calling for coordinated clinical trials infrastructure in the country, saying that the lengthy times now seen in the industry are ratcheting up costs while delaying market entry relative to other markets.

(PM Live) The European Commission has approved an extra tumor indication for Novartis' Votubia (everoolimus), used to treat non-cancerous kidney tumors associated with tuberous sclerosis complex (TSC).

(PharmaBiz) India's health ministry is preparing to assess all State drug testing laboratories-both public and private-to ensure they are compliant with current Good Laboratory practices (CGLPs).

(European Parliament) A new draft report, "on the proposal for a directive of the European Parliament and of the Council relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems."

Essential Reading

(Stericycle) Mike Rozembajgier of the recall firm Stericycle takes a look at the warning letters of 2012 and asks, "What can be learned?"

(EconLib) Researcher Charles Hooper looks at the case of KV Pharmaceutical's drug Makena and wonders about the unintended consequences of FDA's approval process and the political pressures it succumbs to.

(FDA Matters) Steven Grossman explains that an Obama presidency likely means the potential for some degree of transition (though not much), while a Romney presidency would likely bring about the uncertainty typical of any new administration.

(Eye on FDA) Mark Senak has another take on warning letters and notice of violation letters, and breaks them down into some useful categories.

[Editor's note: I have some lengthy appointments out of the office this morning. Rather than leave you with nothing until the afternoon, please enjoy this selection of articles I likely would have written about.]

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