Regulatory Focus™ > News Articles > Regulatory Reconnaissance (1 November)

Regulatory Reconnaissance (1 November)

Posted 01 November 2012 | By Alexander Gaffney, RAC

Regulatory Reconnaissance is your daily news recap for the regulatory news and intelligence space. Top stories today include the announcement of a new committee hearing on the meningitis outbreak, new draft documents out of the Asian Harmonization Working Party (AHWP), new questions regarding what FDA could look like after the election, and a powerful new industry ally for a transparency initiative.

United States

(Senate) US legislators have scheduled a full committee hearing regarding the pharmaceutical compounding crisis. Nearly 30 people have died so far from fungal meningitis contracted after receiving  injectable medicines manufactured by the New England Compounding Center, and the Health, Education, Labor and Pensions Committee says it wants to know how it could have been avoided.

(House) Representative Ed Markey (D-MA) said he plans to introduce legislation that would give FDA new authority to regulate pharmaceutical compounders in the US.

(Kaiser Health News) The use of compounded versions of KV Pharmaceutical's Makena is now getting a second look after the meningitis outbreak.

(FDA) FDA's Cellular, Tissue and Gene Therapies Advisory Committee has changed numerous details of its 29 November 2012 meeting.

(FDA) The weekly batch of FDA warning letters has been posted, and includes allegations of: A generally deficient Institutional Review Board (IRB), two supplement manufacturers selling unapproved drugs, and the unapproved sale of an animal drug.

(CTTI) The Clinical Trials Transformation Initiative recently conducted a workshop on the challenges of antibacterial drug development. The workshops and slides are available here.

(WSJ) Bayer has acquired vitamin manufacturer Schiff for $1.2 billion, reports the Wall Street Journal.

(FDA) An FDA workshop on 5 November aims to explore the value of a Unique Device Identification (UDI) system to healthcare systems and providers.


(EMA) EU regulators want all type-I (minor) variations submitted to it by the end of November. Changes to the rules start on 2 November.

(AHWP) The Asian Harmonization working party is preparing to hold a meeting between 2-6 November, and has released documents detailing what it plans to discuss. Available here: (1) (2) (QMS) (Recalls) (Medical Device AE Form)

(TGA) Australian regulators are reminding sponsors that a new sunscreen standard goes live on 10 November.

(Economic Times) India's Supreme Court appears skeptical of Novartis' patent claim on Glivec, saying it appears too similar to earlier versions to be "new."

(PharmaBiz) India's Pharmexcil wants an export exemption for new generics rules set to go into effect banning the licensing of branded generics.

(EMA) Highlights from the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) include the announcement that PRAC is starting a second safety review regarding concerns with diclofenac-containing medicines.

Essential Reading

(NEJM) The 2011 court case Pliva V Mensing raised some novel issues. NEJM authors ask, how should regulators warn the public about safety risks that may be known to a generic manufacturer, but not to a branded one? A central database and consensus labeling may be two options, they opine.

(Becker ASC) If you missed last week's draft legislative plan for a new track and trace system, you can understand it by knowing three things, writes Jamie Oh: A federal, lot-level system with planned revisions at the 5- and 10-year marks.

(FDA Matters) What will FDA look like after the election? A lot depends on who wins, and whether Margaret Hamburg sticks around. Steven Grossman assesses some potential scenarios. (Part 1)

(Drug Wonks) How will FDA regulate medical applications (apps) going forward? Peter Pitts explains the regulatory framework.

(Forbes) Matthew Herper asks, can a new sleep pill shake up the sleep aid market, or will $2-a-pill generic Ambien prevent new therapies from becoming successful?

(Reuters) Are penalties for violating the Foreign Corrupt Practices Act (FCPA) just the cost of doing business in foreign countries? Some analysts think harsher penalties are needed to deter bad behavior, particularly for pharmaceutical companies like Pfizer.

(Securing Industry) The pharmaceutical anti-counterfeiting market could reach $1.2 billion by 2015, claims a new report from Visiongain.

(The Guardian) The British Medical Journal's new campaign to encourage greater disclosure has won a powerful ally: industry giant GlakoSmithKline.

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