BIOPHARMACEUTICALS AND GENERIC DRUG POLICY – GENERIC SAFETY EFFICACY PURITY – LEGISLATING WHEN A GENERIC IS A GENERIC?

 

Biopharmaceutical “generics” controversy continues on Capitol Hill.  Manufacturers say that the biopharmaceuticals cannot be guaranteed of safety, potency, and purity in the generic sense, since they are proteins and other biological type medications.  This is quite different from the many generic forms of other drugs, such as aspirin, penicillin, and other chemical drugs. 

Why is this such a big deal? 

Biopharm prices are considerable higher than chemical drugs.  Of the $252 billion dollars spent on prescription medicines in 2005, $33 billion was biotech-biopharm types of medicines. All med sales grow about 5-6 % per year, whereas the biopharm group grows about 3 times that rate. The top three selling biopharm meds were neupogen, epogen, and intron A – with costs at about 15, 20, and 22 thousand dollars per patient per year. Imiglucerase, an enzyme drug, will cost about 200,000 dollars per patient per year.  

Large carriers such as Kaiser and others are seeing astronomical increases in these drug costs.    Medicare estimates for drug plans estimated at 395 billion, now is over 650 billion over the ten years initial estimates. 

 In the generic marketplace, drug costs have been reduced about 50-70 percent in general.  However, this truly sensical process may be difficult to add to generic follow-through biotech group of biopharmaceuticals. How will the abbreviated new drug application be changed to allow “generic” or “follow-through” biotech biopharmaceuticals to progress faster to FDA approval?  Certainly, the savings for guaranteeing the purity, safety, and efficacy of the biopharmaceuticals may not be as great.  The big issue still remains whether the profits from “open season” on the off patent biopharmaceuticals will allow for continued research and development for newer and unique and orphan type biotech drugs that will save patients and save money.   

The baby boomers are passing through the biopharmaceutical turnstile now, and with growing numbers. 

How the 1984 Hatch-Waxman Act (Drug Competition and Patent Term Restoration Act) will change and what effect any change will have is to be determined as of yet.  This law allowed rapid development and approval of chemical drugs for generic distribution after patents expired on known brand name drugs. 

 

(Commentary by castMD with adaptation from:  Fuhr & Blackstone's article in Biotechnology Healthcare)  

 

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