Jill Wechsler

Appropriate use of medications promises to improve patient care and curb spending, prompting pharmacists, public health authorities, and manufacturers to promote multiple adherence strategies.

FDA funds research to further development of innovative generics, while working to address review and approval issues.

The Food and Drug Administration may no longer be able to alleviate shortages in vital drugs by permitting the import of unapproved medicines following a decision by the US Court of Appeals for the District of Columbia.

Compounding, tracking legislation moves forward

Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.

Pharmaceutical companies can anticipate more costly, drawn-out patent litigation in the wake of the June 17 US Supreme Court decision, which creates great uncertainty about the grounds for negotiating settlements in patent cases.

The Supreme Court decision blocking patents on naturally-occurring genes has generated predictions of doom for biotech innovation, along with expectations of more healthy competition in discovering new treatments and diagnostics.

Bills to regulate drug compounding and establish a national track and trace system face political and policy differences.

An overview of the latest regulatory developments for malaria drugs, biosimilars, and global standards.

The US Food and Drug Administration and industry have been working to incorporate process validation as an integral component of drug development and production, and to avoid divergent policies in the US and Europe.

Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.

FDA faces budget crunch; Supreme Court hears key cases

Just about every federal program and affected interest group is pressing for relief from the 8% across-the-board cuts in funding imposed by the budget sequestration mandate.

The Obama administration’s budget plan for fiscal year 2014 apparently assumes that the pharmaceutical industry can support Medicare and other health programs through changes in drug coverage and payments.

FDA has come down on the side of reducing abuse of opioid medications, over encouraging wider availability of low-cost painkiller meds.

Opioid abuse generates calls for efforts to curb distribution, develop abuse-resistant formulations.

Latest news about compound pharmacies, biosimilars, prescription drug purchases, and other regulatory topics.

After less than a year on the job, the head of FDA’s Office of Generic Drugs (OGD) has announced his departure, a sign that all is not well with plans for major organizational changes at the Center for Drug Evaluation and Research (CDER).

The greatly feared federal budget sequestration mandate went into effect Mar. 1, 2013, and, initially, the impact was fairly muted.

Vaccine development is benefiting from manufacturing advances and support for global health.

The growing dangers from substandard and falsified medicines around the world has prompted a blue-ribbon panel formed by the Institute of Medicine (IOM) to call for clear international standards for higher quality medical products, plus an electronic tracking system in the US to uncover bogus products in the supply chain.

Prosecutors and regulators challenge manufacturing quality failings likely to cause patient harm.

Federal law enforcers are looking hard at pharmaceutical manufacturers that put consumers at risk by cutting corners on product quality and safety and violating current good manufacturing practices (cGMPs).

In the dog-eat-dog world of federal deficit reduction in the US, there seems to be one health-related spending cut with broad bi-partisan support:

A new international agreement to reduce mercury contamination of air and water was recently adopted by 140 countries, without a proposal that threatened to limit access to vaccines in much of the world.

Biopharmaceutical companies are touting their huge investment in R&D, which has filled the drug pipeline with more potential first-in-class medicines, including orphan drugs, personalized medicines and new therapies based on novel scientific strategies.

Shortages and compounding disaster spur efforts to overhaul manufacturing oversight and stimulate industry improvements.

White House and Congress likely to struggle over funding for bio/pharmaceutical regulation.

Recent change likely to boost drug coverage by plans, but with variation in formularies.

Efforts to repeal the Affordable Care Act (ACA) died on election day, as President Barack Obama won a second term in the White House and the Democrats maintained control of the Senate.