Jill Wechsler, Pharm Exec’s Washington Correspondent

The federal Open Payments program is finally reaching its goal-to halt the adoption of multiple “transparency” initiatives by states and local governments with a national system for collecting and disclosing data on industry payments. Will it make a difference?

A long list of high priority issues requiring immediate attention on Capitol Hill leaves little time to consider drug access proposals that have limited bipartisan support, writes Jill Wechsler.

Before leaving Washington for a delayed August recess, the Senate voted 94-1 to approve legislation reauthorizing user fees and a series of program changes critical to maintaining a smoothly functioning FDA medical product review and approval process.

The growing toll requires new assessment of risks, expanded provider education, and more scrutiny of marketed products.

Pharma companies have been protesting expansion of the federal program that provides deeply discounted prescription drugs to certain hospitals and health providers serving low-income, uninsured patients.

Excitement over more new treatments for cancer and rare diseases is offset by cringing over prices.

The FDA ruling that exempts biosimilar makers from waiting an extra six months after approval to distribute a new product should help overcome delays in future biosimilar sales, writes Jill Wechsler.

Congressional measures lack the support to move forward, writes Jill Wechsler.

New legislation, administration priorities raise multiple challenges for new commissioner.

The Center for Biologics Evaluation and Research is gearing up to facilitate the development and approval of regenerative medicine advanced therapies (RMAT), as defined by the 21st Century Cures Act.

The Senate confirms Scott Gottlieb as FDA commissioner. User fee reauthorizations, a hiring freeze, and the opioid epidemic are a few of the issues awaiting the agency's new leader.

Payers and pharma companies seek outcomes data for evidence-based reimbursement deals.

Amidst hundreds of presentations on new developments in cancer research and treatment discovery at the AACR meeting this week, FDA policies for speeding promising new therapies to patients garnered a good deal of attention.

Greater patient involvement in regulatory processes is raising questions about whether the views expressed by such groups fully reflect broader public needs and values.

Jill Wechsler outlines how the new FDA commissioner tasked with curbing regulation, speeding approvals-and collecting more fees to do it.

Jill Wechsler outlines how the new FDA commissioner tasked with curbing regulation, speeding approvals-and collecting more fees to do it.

FDA efforts to speed more new generic drugs to market probably won’t do much to reduce high drug prices, writes Jill Wechsler.

Attack on treaties and imports threatens international operations.

February 17, 2017

In promising to expedite and simplify the FDA approval process, Donald Trump fails to take account of industry's appreciation an efficient, rigorous FDA regulatory system, writes Jill Wechsler.

Congress is poised to tackle exorbitant drug prices through health reform and FDA legislation.

January 30, 2017

Health reform, pricing pressures will shape drug marketing and development in 2017, writes Jill Wechsler.

Health reform, pricing pressures will shape drug marketing and development in 2017.

Congress's enactment of 21st Century Cures legislation may have given pharmaceutical manufacturers an early Christmas present, but some concerns are being voiced, writes Jill Wechsler.

Republican control of Washington promises overhaul of healthcare and medical product regulation.

Congress took a major step yesterday towards shoring up FDA operations and biomedical research supported by the National Institutes of Health with House passage of the 21st Century Cures bill.

Biopharma companies should no longer consider FDA an obstacle to innovation and in need of major reform, according to Jim Greenwood, President of BIO.

The surprise victory of Donald Trump opens the door to new strategies for providing healthcare to Americans, including coverage and oversight of prescription drugs.

FDA officials agree that large comparative clinical trials defeat the purpose of the abbreviated development program for biosimilars.