Medical Device Regulation Dilemma

Spotlight on Medical Device Regulation Policies

On 7 February, President Obama gave a speech to the Chamber of Commerce during which he addressed some issues regarding regulations, such as:

We’re improving the way FDA evaluates things like medical devices, to get innovative and life-saving treatments to market faster.

According to the FDA’s device regulation and guidance, medical devices are classified into Class I, II, and III.  Most Class I devices do not require notification.  Most Class II devices require premarket notification 510(k) and most Class III devices must have both 510(k) clearance and receive premarket approval.  In other words, the higher the class, the more stringent the regulatory requirement.  Recent news about medical devices is centered on 510(k).  So what is 510(k)?  From FDA’s website:

The 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA).

Medical Device Review Standard Challenged

Recently, the FDA has reviewed its 510(k) approval actions, aiming to streamline and shortening review processes.  But there were alarming signs that past review processes already existed flaws that could potentially challenge the FDA’s attempt to simplify medical device review processes. For instance, the New York Times reported that in the past five year there were over 68 recalls and more than 22,000 reports of malfunctioning external defibrillator devices.  This prompted the FDA’s advisory panel to request tighter oversights.  A study also found that about 70% of the recalled devices received FDA abbreviated agency protocol review, which again alerts current regulatory processes.  Despite these seemly increasing numbers of recalls and defective devices, medical device makers complained that the FDA’s stricter and prolonged regulatory scrutiny had already forced them to move operations to overseas, like China, Brazil, India, and Europe.  Again FDA is sandwitched between medical device makers who prefer simpler approval processes and consumers who demand stricter standards and safer devices.  A tough role.

Greenlights on Recent Medical Devices

From my Google Alert notice, at least four companies received greenlight on their 510(k) clearance and approval, here they are (and hope more to come):

1. Diazyme’s 25-Hydroxy Vitamin D Assay (January 24, 2011)

2. Pacific Consolidated Industries’s On-Site Oxygen Generators (February 7, 2011)

3. Depuy Orthopaedics’s New Titanium Foam Implants and revision hip system (February 15, 2011)

4. Allergan’s Lap-Band Device (February 16, 2011)

Until next post, keep on reading and writing!!

Eyes on Follow-On Biologics

Drug Approvals Sliding and Patent Cliff Approaching

Drug development is a painfully slow, costly, and risky business.  It’s a hit or miss and the odds can be a multi-billion dollar question.  In 2010, the FDA approved 21 new drugs (new molecular entity and biologics), slightly down from 25 drugs in 2009.
These 21 drugs from the FDA database (NDA Chem Type 1 and BLA) are:

Company Brand Name Active Ingredients
ACORDA AMPYRA DALFAMPRIDINE
NOVO NORDISK INC VICTOZA LIRAGLUTIDE RECOMBINANT
GENENTECH ACTEMRA TOCILIZUMAB
SHIRE HUMAN GENETIC VPRIV VELAGLUCERASE ALFA
AUXILIUM PHARMS XIAFLEX COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
CHEMISCH FBRK KRSSLR ASCLERA POLIDOCANOL
ORPHAN EUROPE CARBAGLU CARGLUMIC ACID
BAYER HLTHCARE NATAZIA DIENOGEST; ESTRADIOL VALERATE
GENZYME LUMIZYME ALGLUCOSIDASE ALFA
AMGEN PROLIA, XGEVA DENOSUMAB
SANOFI AVENTIS US JEVTANA KIT CABAZITAXEL
VISTAKON PHARMS LLC LASTACAFT ALCAFTADINE
MERZ PHARMS Xeomin incobotulinumtoxinA
LAB HRA PHARMA ELLA ULIPRISTAL ACETATE
NOVARTIS GILENYA FINGOLIMOD
SAVIENT PHARMS KRYSTEXXA PEGLOTICASE
BOEHRINGER INGELHEIM PRADAXA DABIGATRAN ETEXILATE MESYLATE
CEREXA TEFLARO CEFTAROLINE FOSAMIL
SUNOVION LATUDA LURASIDONE HYDROCHLORIDE
THERATECHNOLOGIES EGRIFTA TESAMORELIN ACETATE
EISAI INC HALAVEN ERIBULIN MESYLATE

I can imagine even just “one” more drug being added to the list can mean huge revenue to a company, hope to patients, and rewards for collective efforts from hundreds, if not thousands, of people involved during the drug development and evaluation processes.  So the declining drug approval number (from 25 to 21) is a warning sign to the industry.  To make matter worse, Nature news reported that looking forward, drug companies will encounter the most fierce competition from the generic drug makers in 2011 and 2012 because many blockbuster brand name drugs will face patent expiration.  Together, thinning drug pipelines, patent cliffs, and stricter regulatory policies all put heavy pressure on drug companies.  How will the drug companies react?

Biosimilars = Follow-On Biologics = Me Too Drugs

When the patent of a brand-name drug from the pharmaceutical/biotech company XYZ expired, other companies are allowed to copy the formula to make the same drug, called generics, to sell for a lot less and then to compete with THAT brand-name drug.  Imagine a secret recipe is published from a world-renowned chef in a three star Michelin restaurant, so now you and I and everyone can follow the instruction to make the same food, well, in theory.  In order to not lose much revenue after patent expiration, many drug companies have gradually stepped into generics market and have gone to lawmakers for help.  Recently, Merck & Co shook hands with contract researcher Parexel International Corp to develop biosimilars.  Biogen Idec Inc. also plans to expand into biosimilars as they will provide meaningful revenue streamSimilar interests from several big pharmaceutical companies were also expressed in the January’s JP Morgan healthcare conference in San Francisco.  It seems there will be a stronger competition in the years to come.

Until next post, keep on reading and writing!