GLG News by Generic Pharmaceuticals Regulation Experts: Healthcare Consultants

Generic medication (unfortunately) is here to stay. Generics erode the profits of the true innovators and cannibalize the innovators profits. Moreover, generic drugs have established safety and some form or bio-equivalence rating. No matter what the BIG pharmaceutical companies do the physician will...

The article glossed over issues such as pharmacist/pharmacy involvement, tablet scoring, and narrow thereapeutic range drugs, all of which can can profound impact into this practice.

The drive for this new Wyeth drug Lybrel is to capture market share in a saturated birth control market.

cost ease of use

-side effect profile -3rd party reimbursement -patient cost

The side effect profile and impact will be the key indicator whether this product is as successful as it can be.

Patients may have little understanding of a particular disease state or how to treat it, but with TV advertising they are asking their physicians to prescribe a particular advertised product which is usually quite expensive. There are usually comparable treatments available at a lower cost.

This author has written on generic biologicals, and agree’s with the article.

Lobbyists are seeking to influence Congress Some Congressional leaders "get it" bio-studies are needed for Biologicals because of the large potential difference in strains of biologicals. The Commissioner of the FDA will need to file a report for Congress to provide justification. Generic drugs were...

Increasing population will desire more medications Thai IP will play a large role in determining which medications can be released generically. Japan is perhaps the most restrictive drug regulatory body, not even the ominous FDA is as tough. So-Called Counterfeit drugs are not the FDA’s concern unless...