FDA Office of Generics Points to Record-Setting 2016 Ahead of Next Week’s Hearing

Kathleen Uhl, director of the United States Food and Drug Administration's Office of Generic Drugs (OGD), also unveiled another record year for generic drug approval.

Next Thursday, the House Energy and Commerce Committee will hold a hearing to discuss the reauthorization of generic and biosimilars user payment programs that help fund the agency to accelerate approvals.

The new chair of this commission, Rep. Greg Walden (R-OR), said his committee will take representatives. Kurt Schrader (D-OR) and Gus Bilirakis (R-FL) to accelerate generic drugs in the market and create a new Priority Review Program (PRV) bonus for generic drugs to promote development.

The meeting will also discuss the upcoming iteration of the Generic Drug Use Fee Act (GDUFA II), which complements Congressional funding in exchange for more generic approvals at a faster schedule and prioritized revisions for certain generic and Next iteration of Biosimilar User Rates Act (BsUFA II), which will be crucial for the FDA as it reviews an increasing number of 351 (k) applications.

EMT Report

In 2016, OCD FDA approved 73 generic first (an alternative to a branded product, where there were none before) and a total of 630 New Drug Abreast (ANDA) applications and provisionally approved 183 or 87 record set in 2015 for the Number approved in the history of the FDA.

A new FDA staff in contact with the industry, with more than 4800 requests for information, more than 1800 matches and controls more than 1800 complete response letters detailing the comments and questions that must be addressed by the applicant.

In addition, EMT 158 issued new product guidelines, many of which had complex dosage forms, such as auto-injectors, inhalation powders, nasal sprays, topical products and ophthalmic products. There are more than 1,500 in the line guidelines.

The FDA also provided funding to 16 new outside researchers to conduct regulatory science activities that complement the business, and OGD has conducted 87 ongoing external research collaborations, by the end of 2016.

Regulatory Recon: Rep. Cummings

Regulatory Recon: Rep. Cummings Wanted to Talk Drug Prices With Trump; ANVISA Developing New Device Regulations

In Focus US:

• Cummings contradicts Trump in meeting the price of medicines (Baltimore Sun)
• Hundreds of Zika tests that test in US laboratories (Reuters) (Forbes)
• Trump said he will introduce health reforms in early to mid-March (Reuters 1, 2)
• Republican House Leaders Describe Replacement Plan for Obama Health Care Act (New York Times) (Reuters)
• Republican disease proposal would shift the rich to poor money (New York Times)
• Trump's election to lead health agency puts EpiPen 'disturbing' issue (Reuters)
• CMS nominated ducks price problems (BioCentury) (The Hill)
• MP links to foreign reviews of Biotechnology opinion (KHN)
• FDA Issues Frequently Asked Questions About Pharmaceutical Product Development and Manufacturing (FDA)
• CDER 2016 Update for Rare Diseases (FDA)
• A Closer DNA Computer "Smart Drugs" (Phys.org)
• MicroRNA Therapeutics: A New Era for Treatment of Cancer and Other Diseases (Nature)
• Biopharma in 2016 (Nature)
• Regulatory clock: The target product profile for the regulatory tool advantageous but underutilized (Nature)
• CTTI provides recommendations for pediatric clinical trials for antibiotics (Focus)
• GAO: FDA's ability to monitor drug shortages remains a concern
• House Bill aims to add mandatory FDA drug recall withdrawal Arsenal (Focus)
• Industry groups FDA petition on revisions to the intended use rule (Focus)
• 'Tsunami' of Alzheimer's cases among Latinos raises concerns about the costs of care (KHN)
• Amgen hide information from biosimilars, Genentech claims says ($ Law360-)
• Cheapest drugs from Canada? Pharma despise the idea, but the best senators grow HHS chief to deal (fierce)
• Xeljanz Pfizer alone can not match Humira for Abbvie in the big Miss RA head-to-head (fierce) (Presse)
• The Alexion million transaction is largely lost (the street)
• Baxalta buys a big jump in sales in the fourth quarter of Shire (PharmaTimes) ($ PharmaLetter-)

In Focus International:

• Regulation of ANVISA Brazil for personalized sanitary products (Emergo)
• Canada tries to apply a biosimilar equilibrium law ($ -pink sheet)
• EC will not provide a timetable for the phasing out of research on non-human primates (Focus)
• EMA weighs a new guideline on quality requirements for combination products (Focus)
• Daiichi, worried lutantinib ArQule fails in liver cancer stage 3 (fierce) (Presse)
• Martina Schüssler-Lenz elected as new chair of the Committee on Advanced Therapies (EMA)
• Uniqure three-pin gene therapy trial program details (fierce)
• Etanercept biosimilar submitted for approval in Japan (Gabi)
• Takeda buys ARIAD purchase (PharmaTimes)
• Takeda and TiGenix announced a successful test of Crohn's disease (Feroz) (Presse)
• The Mali study shows the effectiveness of the new malaria vaccine ($ PharmaLetter-) (NIH)
• Swiss VC launches new fund with the aspirations of orphan drugs ($ scriptures)
•  Health Canada approves HIV drug Odefsey ($ PharmaLetter-)
• Eisai Comtan and Stalevo markets in China ($ PharmaLetter-)

US: Pharmaceuticals & Biotechnology 

• The common final rule: Many keep or eliminate, but not much new added (FDA Blog Law)
• Oncology Practitioner, Doctor Practice Manager and pay $ 1.7 million to settle charges he billed Medicare for illegally-imported drugs (DoJ)
• Flu vaccine protects half of the time, according to the CDC (NBC) (Medscape)
• Amygdala becomes a drug candidate for Gilead (Ferocious) (Presse)
• The future of successful generic and commercial strategies (Pharmafile)
• FDA asks for comments on pediatric and post-marketing pharmacovigilance of drug use Comments (FDA)
• The return of the one-stop shop model is simply an OCM marketing ploy?
• (InPharmaTechnologist)
• Charles River separates and sells activities OPHRDC (OutsourcingPharma)
• The orientation of phospholipase D in cancer, infections and neurodegenerative diseases (Nature)
• Basic results on apoptosis selective inhibitors of the Bcl-2 family (Nature)
• Inhibitors of JNK stimulate antifungal immunity (Nature)
• How Sanofi blew his chance with Actelion (Drug Delivery)
• AmpliPhi advances the clinical phage for the treatment of microbial infections ($ scriptures)
• FDA extends Boehringer asthma approval to include children ($ PharmaLetter-)
• Sage therapeutic supplies and cushions its own rumors of mergers and acquisitions (fierce)
• Insulet opens a factory in Acton, Massachusetts. (Drug Delivery)
• Zoetis reports that the pace gains, so why do stocks that fold? (The street)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

• The drug giving positive results against chemotherapy for breast cancer AstraZeneca (Pharmafile) (PMLive) (Presse)
• FDA review of Mylan / Biosimilar Biocon Neulasta (BioCentury) (Economic Times)
• Celgene Announces Positive Phase III Oral RAYO Ozanimod Trial in Patients With Recurrent Multiple Sclerosis (Press)
• Perrigo announces FDA approval for the end of hydrocodone bitartrate and oral homatropine methyl bromide solution (press)
• Zydus Cadila receives two FDA approvals (Pharmafile) (Economic Times)
• Aimmune Therapeutics provides an ongoing program update Phase 3 AR101 for peanut allergy based on feedback from FDA (Presse) 

US: Medical Devices:

• Vascular solutions shareholders approve acquisition of Teleflex $ 1M (MassDevice)
• J & J announces the publication of an NEJM study on bariatric surgery for type 5 diabetes mellitus (MassDevice
• FDA Expands Indication for Cryoablation Catheter Freezor Xtra Medtronic (MassDevice) (Presse)
• Medtronic has the Signia stapling system, the innovative surgical stapler for minimally invasive surgery (press) 

US: Assorted & Government:

• UnitedHealth pursued by the United States government on health insurance costs (Reuters)
• The fight against breast implants should remain in court, according to the Brazilian company ($ Law360-)
• Celgene files $ 198.5 million patent application ($ FDANews-)
• Treatment differences persist between low-income workers and high-income workers, even with insurance (KHN)
• Something we can all support: H.R. 985, where Lift Off Left CAFA (Drug Devices Act e)
• Align Technology secures ClearCorrect patent dispute victory

Upcoming Meetings & Events

• FDA Advisory Committee Calendar 

Europe:

• A new framework to stimulate research, innovation and growth? (Dehns)
• Update on the procedure for requesting Conventions and Meetings (AIFA)
• EBITDA and EFPIA supports the ARM initiative on hospital exemptions and require greater transparency in all advanced cell, gene and tissue therapies (EFPIA)

Asia: 

• Difficult to detect, China's bird flu virus may be more common (Reuters)
• Japan supports wireless pacemaker Medtronic Micra (MassDevice) (Presse)
• Medigus wins a nod to the Chinese test of trans-muscular stapler (MassDevice)

 India:

• The support policy needed for the pharmaceutical industry to maintain momentum for growth: FICCI president (PharmaBiz)
• New stents disappear from hospitals to 're-label' (Economic Times)
• Cipla, Serum Institute launches hepatitis B vaccine (Economic Times) 

Australia: 

• MiniMed 640G insulin pumps (TGA) 
• Prima Biomed launches new I-S lead drug test, but needs more money, analysts say (fierce)

 Canada:

 12 arrested in Ottawa for counterfeit prescription drug network (Industry Assurance)

Regulatory Recon: Tom Price Confirmed as HHS Secretary

Regulatory Recon: Tom Price Confirmed as HHS Secretary; FDA Approves Marathon's Emflaza for DMD (10 February 2017)

IN Focus US:

• Tom Price is confirmed as Secretary of Health (New York Times) (NPR) (Washington Post) (SNL)
• Public Citizen's Trump Challenges Liquidation Order (Pink Leaves $) (BioCentury)
• Trump wants the FDA to be moving faster. Your actions have the opposite effect (Vox)
• Rapid drug approvals are risky, but drug companies have another idea that is simply terrible (Los Angeles Times)
• Three decades of pandemic threats can teach us about the future (Health Affairs blog)
• Often, FDA's fastest advocates, patient groups will resist deregulation Trump (Xconomy)
• Heat in pharmacy benefits managers is construction (Axios)
• Americans discourage medical treatment because they can not afford (the Atlantic)
• The HHS internal memory: Some employees will be exempt from ambush FDA hiring (Focus)
• Details of FDA filing requirements for post-marketing safety product combination (focus)
• FDA warns of stomach swelling risks to treat obesity (Focus)
• FDA approves for DMD Emflaza Marathon (MedPage) (FDA) (Reuters) (Presse)
• Senators question Kaleo's $ 4,500 opioid overdose label (Reuters)
• The leader of personalized medicine for the FDA comes out of the initial liquid biopsy Grial (GenomeWeb) (BioCentury)
• The big pharmaceutical industry faces costly failure in the fight against cancer (Financial Times)
• FDA industry petitions against a new standard for intended use (BioCentury) ($ Law360-)
• The pair hope drug Regeneron against eczema due to slow sales of Eylea (Reuters) ($ PharmaLetter-)
• Dozens of new anticancer drugs to improve survival, frustrating patients (KHN)
• Immunomedics a licensing agreement of up to 2 billion with Seattle Genetics (Reuters)
• Slow Medicine: Examining Laser Surgery Tests (MedPage)
• FDA of the United States is probably not "significant" could be largely saved by the order of reducing regulatory Trump ($ -pink leaf)
• Eve of the test: clinical trial cycles continue to rise despite the efforts of industry (Nature)
• How long will we end up with $ 100,000 of cancer drugs? (Cell phone)

In Focus: International

• Operational challenges as European regulator is preparing to leave the UK headquarters (BioWorld)
• The EMA Group recommends that the use of Uptravi Actelion may continue (Reuters) (EMA)
• Highlights of the meeting of the Pharmacovigilance Risk Assessment Committee (PAC) 6-9 February 2017 (EMA)
• Purdue look for a rule that would give him an edge in the Canadian analgesia market (Reuters)
• European regulatory summary: ENVI budget request EMA for Brexit volatility (Focus)
• Brexit could delay major drugs for UK patients, former president claims MHRA (Pharmafile)
• ICH E6 addition integrated display (R1) (ICH)
• Kitov opens on allegations of fraud, takes Commerce (OutsourcingPharma) (Presse)
• Daiichi axis Japanese site R & D and a month after the Indian unity of the abolished research (fiera)
• Seminar Report PMDA medical devices ATC-2016 (PMDA)
• The best forms of electronic application of the EU become mandatory in March (Fair)
• Sanofi's "conservative" India vision for the initial launch of Dengvaxia ($ scriptures)
• A new formulation of a drug for the old can formulate a CCP? The European Court decided (petal of rose $)
• Workers protest against the Merck plant in Goa, will require a salary review (Indian Express)

US: Pharmaceuticals & Biotechnology

• The price of everything and the value of nothing (eye for Pharma)
• Dissuasive Abuse and 3-Year Exclusivity: FDA Decisions Clarify Content and Focus on Exclusively "Abuse" (FDA Law Blog)
• Doctors see gains against an "immediate threat", C. Difficile (New York Times)
• States enter into price issues - Look out down! (Lachman consultants)
• The Indian company Vikshara Trading & Investments Ltd denies FDA inspection, placed on the import alert (FDA)
• More lost than won in the planned R & D change (EP Vantage)
• Momentum NSCLC Merck and Roche, augurs well for scripture combinations ($)
• TRACON slides as brain cancer test loses the mark (fierce)
• Epilepsy discovered in the fish model is promising in the small pediatric clinical trial (NIH)
• Anti-cancer drug for dogs (Paccal Vet-CA1) already approved (FDA)
• What will happen when you have a disease doctors can not diagnose? (National Public Radio)
• BIAL signed a mega-million agreement for Parkinson's disease $ in North America ($ PharmaLetter-)
• Ovid, NeuroPointDX team on rare disease tests (fierce)
• Biosimilars in 2016: Highlights (Gabi)
• Non-biological complex drugs and pharmacopoeia (Gabi)
• 1,000 patients Phase III trial for Armetheon required prior to FDA approval (EPR)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

Aslan reports results of Phase II varlitinib before the IPO (BioCentury) - See more about:

US: Medical Devices

• FDA Approves 7D Reassignment Image Guided System for Spinal Surgery (MassDevice)
• Physio-Control Recalls LIFEPAK15 Monitor / Defibrillator Due to the failure of an electric shock delivery (FDA)
• Alaris syringe pump (high flow), 8100 and AIL sensor kits by CareFusion: withdrawal Class I - Error Alarm (FDA)
• Medicare reduces the cost of knee replacement (This is how it could be counterproductive) (Forbes)
• Cheap method for printing Lab-on-Chip Diagnostic devices and instruments Revolution (Medgadget)
• Silicone trading game Dow Chemical: what it means for medical technology (MassDevice)
• The first patients in the pivotal trial of Echopulse Theraclion device (MassDevice)
• Abbott initiates withdrawal of the vascular closure system StarClose SE (MassDevice)
• BIOLASE announces the launch of the FDA and the worldwide launch of the new Waterlase® Express ™ (All Press)

US: Assorted & Government

• The tax authorities are considering drug prohibition and 20 state prosecution ($ Law360-)
• Nebraska Daubert Order a mile from the expert mouth, but only six inches (law and drug devices) deep
• The federal judge approves the Consent Decree with the California Food Supplement, Regeneca Worldwide (FDA)

Upcoming meetings and events

Europe

• Adapted and reduced clinical program for biosimilars (Gabi)

Asia

• China punishes hospital staff to patients infected with HIV, hepatitis B (Reuters)

India

• Aurobindo sees America plant amid thrust Donald Trump in employment (Economic Times)
• Maha FDA to follow a company based in Mumbai for the storage and supply of illegal orthopedic implants (Pharmabiz)
• A 3-stent implant in India is probably unnecessary (Economic Times)
• Dr. Reddy launches generic drugs in France; Develops its activities in Europe (Economic Times)
• India to allow API companies to request EU quality confirmations online (InPharmaTechnologist) World Health Groups in arms against Roche for the "inhuman" price of its anti-breast cancer drug (trastuzumab Pharmabiz)

Australia

• The implementation of reforms - the public consultation forecasts (TGA)

Zika

• Zika doctor warned Brazil against reducing the guard of congenital malformations (Reuters)
• Another international
• Statement of position on the approval of biosimilars in Latin America (Gabi)
• General health and other interesting articles
• The first genetic transmission in mammals could help the great New Zealand eradication plan (MIT Technology Review)

Regulatory compliance is our daily intelligence report for the Regulatory Affairs area, which gives you the best of the new regulations around the world. Each day of the week, our objective is to present the last moments of the approval of new developments, meetings, legal and political, regulations and guides, as well as the latest trends that can affect the professionals of the regulators and the industry in the That work.