Drug Manufactures Forced Out of Business : Fed Regulations Suffocating

Now that government intrusion has brought our health care insurance system to destruction  now it appears the very bases for drug development is under attack by federal regulations, forcing the manufactures of antibiotics and other drug development to shrink or go completely out of business.

I wonder who voted for this dire situation, twice?

 A World Without Antibiotics
Source: David Longtin and Henry I. Miller, "The Grim Prospect Of Life Without Antibiotics," Forbes, June 4, 2014.

June 11, 2014

Fewer companies are developing antibiotics, according to biomedical writer David Longtin and molecular biologist Henry Miller.

Multidrug-resistant (MDR) organisms are growing in number. In some cases, there are no antibiotics that can work against them. According to the Centers for Disease Control, the problem is dire: infections that could easily have been eliminated five years ago with antibiotics now have no cure. In 2011, there were 750,000 hospital-acquired infections in the U.S. Of that number, 75,000 patients died while being hospitalized.

As bacterial resistance has grown, the number of companies developing new antibacterial agents has shrunk, partly due to the relatively low return on investment and regulatory requirements.

In 2002, the Food and Drug Administration (FDA) changed the requirements for testing of antibiotics, more than doubling the number of patients required in late-stage antibiotic clinical trials. The result? Fewer companies wanted to perform antibacterial research. Since 2002, most pharmaceutical companies have abandoned their research and development programs for antibiotics.

The FDA's policy towards antibiotics has been misguided. The agency even proposed a rule that would make patients in clinical trials for hospital-acquired pneumonia ineligible for the trials if they had received an antibiotic within 30 days prior to the participation, making the studies all but impossible to conduct.

Longtin and Miller offer a number of policy proposals to encourage antibiotic development:

• The FDA should adopt a Limited Population Antibacterial Development (LPAD) pathway, a concept developed by the Infectious Diseases Society of America which would study new drugs in smaller, quicker, less expensive trials. The drugs would be approved for use for those in well-defined populations for whom the drug has been proven effective.
• Returns on investment from antibiotic development should be level with that of other drug classes. The DISARM (Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms) Act of 2014 would require the Centers for Medicare and Medicaid services to reimburse more for LPAD antibiotics in order to cover their cost. As it stands now, hospitals often lose money because reimbursements do not even cover the cost of some drugs.
• A "priority review voucher" could give the holder the opportunity to move his drug to the top of the FDA agenda, or he could sell the voucher to another company. Such a voucher was developed in 2007 and can cut review time down substantially. The program should be expanded to include all drugs to treat infections.

With better regulation, the U.S. could halt the trend toward the end of the antibiotic era.