FDA Creates New Opportunity in Generic Drug Development

Recent events have occurred within FDA that promise to bring previously unavailable therapeutically equivalent generic drug formulations to the U.S. market.  Patients, prescribers, pharmacists and generic manufacturers all stand to gain from these initiatives:

On June 21, new FDA Commissioner Scott Gottlieb announced (in FDA Voice) that “Too many patients are being priced out of the medicines they need. While FDA doesn’t have a direct role in drug pricing, we can take steps to help address this problem by facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines.”

How might this be accomplished? The answers have emerged rapidly and are good news indeed.  Also in the June 21 FDA Voice article, the Commissioner announced a new Drug Competition Action Plan.  Six days later, on June 27, FDA took the unprecedented step of publishing a list of off-patent, off-exclusivity branded drugs without approved generics.  The agency intends to update this list every six months!

At the same time, the agency implemented a new policy designed to “expedite the review of generic drug applications where competition is limited.” One of the key components of the policy is expedited review of ANDAs until there are three approvals for the given product.

PDG’s founder and President has experience with over 150 ANDAs, and several were the first formulations to enter the marketplace.  PDG sees Commissioner Gottlieb’s new program as leading another renaissance in generic availability, and is uniquely positioned to help you capitalize on this unique opportunity.

In addition, one of our key strengths is our work with complex dosage forms such as inhalers, injectables, extended release, and transdermals (among others) and the patient/volunteer populations required for their evaluations.  Another strength is our wide range of experience across disease states including therapies directed at cardiovascular, neurology, psychiatric, endocrine, gastrointestinal, pulmonary, analgesic, oncology, anti-infective indications and various other medical needs. Compounding the value of these competencies are our efforts with diverse patient populations, including pediatric, elderly, at-risk, sufferers of acute and chronic illnesses as well as those patients with intermittent medication needs.

Feel free to contact PDG today to accelerate your generic development program by taking full advantage of FDA’s new initiative!