On the heels of last week’s study showing that generic pharmaceuticals saved US consumers around a trillion dollars over 10 years, the Generic Pharmaceutical Association (GPhA) took the opportunity to advocate for the strategy known as pay-to-delay.  Read more »

Improving lives for less—that’s the tagline from the press release from the Generic Pharmaceutical Association (GPhA) describing the results of an IMS study of the savings produced by generic medicines. The study, Generic Drug Savings in the US, found an impressive $1 trillion in savings over a ten-year period (2002 through 2011). Read more »

This week, KV Pharmaceuticals filed a lawsuit against FDA to force the agency to stop compounded versions of their synthetic progesterone drug, Makena (hydroxyprogesterone caproate), from being produced. Read more »

The recent announcement that GlaxoSmithKline will pay a record $3 billion in civil and criminal penalties marks the largest settlement ever incurred by a drug company, and underscores a trend in larger and larger penalties imposed by the Justice Department for off-label drug promotions and violations of the False Claims Act. Read more »

Roche’s recent announcement that it will be closing its venerable Nutlley, NJ R&D site is the latest in a string of mergers and reorganizations that have resulted in the loss of thousands of life-sciences jobs from New Jersey, and an exodus of both R&D and manufacturing from a state known as the home of big Pharma. Read more »

The House Appropriations Committee released the fiscal year 2013 Agriculture Appropriations bill, which, sets proposed spending levels for FDA as well as for other programs. The bill calls for nearly $ 2.5 billion in discretionary funding, a cut of $16.3 million, or 0.7%, below last year’s level. Total proposed funding for the FDA, including user fees, is $3.8 billion. Read more »

Guest blog written by Reid Paul.

In contentious three days of hearing on the Affordable Care Act, the Supreme Court now seems far more likely to overturn the landmark legislation. Given the strong support the bill originally received from the industry, does overturning it benefit or hurt pharma? Read more »

Amid one of the most divisive eras in our nation’s political history, one thing we can all pretty much agree on is the fact that our stalled economic engine needs a jumpstart. Read more »

A short time ago, I wrote about the Transforming the Regulatory Environment to Accelerate Access to Treatments Act, (TREAT), legislation proposing to modify the regulatory environment to speed the approval of drugs intended to treat life-threatening conditions for which there are no effective therapies. This week brings us the Faster Access to Specialized Treatments (FAST) Act, introduced by Rep. Clifford Stearns (R-FL) and Rep. Ed Towns (D-NY) to the House Committee on Energy and Commerce on Mar. 5, 2012. FAST proposes to amend section 506 of the Federal Food, Drug, and Cosmetic Act to expedite approval of drugs for serious or life-threatening diseases or conditions. Rep. Stearns explains in a press release, “This measure codifies much of the Accelerated Approval regulations into statute and modernizes the program to reflect the amount of medical and scientific innovation that has occurred in the past 20 years.” The aim of the legislation is to encourage FDA to make full use of the accelerated approval pathway to speed the approval of life-saving drugs.

FAST enjoys the support of The National Organization for Rare Disorders (NORD) and of the biotech industry group, BIO. Jim Greenwood, president of BIO, said in a release, “Like the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, S. 2113, which was introduced by Senator Kay Hagan (D-NC), the FAST Act will update the Accelerated Approval process at the FDA so that it works in a transparent, predictable way for all therapies intended to treat debilitating conditions for which there is an unmet medical need. Making this change will better enable biotechnology companies to bring new, safe and effective treatments and cures to patients in need at the earliest point in time.”

Time is of the essence for those with rare diseases or with other conditions for which there are no effective therapies. Certainly, FDA should do its part to get therapies to market in the shortest time possible, and the introduction of two similar bills in such a short time span underscores the public’s impatience with the drug development process. However, human physiology is complex, drug development is hard, and FDA always has to balance speed with safety. Will urging FDA to go faster bring the desired results?

Senator Kay R. Hagan (NC) introduced a piece of legislation called the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act. The bill is intended to accelerate the approval process for medicines targeted to conditions for which there are no effective treatments. The bill will be referred to the Senate Health, Education, Labor and Pensions (HELP) Committee that oversees healthcare issues. Read more »